Isomalto-Oligosaccharides (IMO)

Evidence Level
Limited
7 Clinical Trials
6 Documented Benefits
2/5 Evidence Score

Isomalto-oligosaccharides (IMO) are short chains of glucose joined mainly by alpha-1,6 bonds, such as isomaltose, isomaltotriose and panose, made from corn or tapioca starch with enzymes and sold as a syrup or powder sweetener and bulking agent. Commercial IMO also contains glucose, maltose and other easily digested sugars in amounts that vary by product. IMO is often sold as a fiber, but human studies show much of it is digested and absorbed in the small intestine: in crossover tests, blood glucose and insulin rose about as much as after the same amount of dextrose, and little reached the colon to be fermented. The FDA has declined petitions to add IMO to its list of carbohydrates that count as dietary fiber, while Health Canada accepts it as a fiber. Gains in bowel movements and gut bacteria come from small studies without randomization, while randomized trials found no change in bowel movements or bifidobacteria.

Studied Dose 10 g/day for 30 days to 8 weeks in older adults; 30 g/day for 4 weeks in hemodialysis patients; 36 or 54 g/day for 4 weeks in an unpublished trial in healthy adults; 10 g/day for 7 days and 15 g/day for 1 week in microbiome studies; single doses of syrup giving 50 g of carbohydrate in glucose tests.
Active Compound A mixture of glucose oligomers made enzymatically from starch, mainly alpha-1,6-linked isomaltose, isomaltotriose and panose, plus glucose, maltose and other alpha-1,4-linked sugars in amounts that vary between products.

Benefits

Stool frequency and stool output

In 7 older men, 10 g/day for 30 days doubled defecation frequency and raised wet stool output 70% against a prior low-fiber period, and in 13 older adults wet fecal mass rose 24% over a placebo period. Neither study was randomized and enemas were allowed. In an unpublished 4-week randomized placebo-controlled trial in healthy adults, 36 or 54 g/day did not change bowel movements.

Gut bacteria counts across human studies

In a study of 13 older adults without randomization, 10 g/day raised fecal bifidobacteria and lactobacilli over a placebo period. In a randomized placebo-controlled screening in healthy adults, 10 g/day for 7 days did not raise bifidobacteria, and 15 g/day of an IMO product for 1 week left microbiota diversity unchanged in healthy women. Bacteria counts are markers, not health outcomes.

Blood glucose and insulin rise about as much as after dextrose

In two randomized crossover tests in healthy adults, IMO syrups matched to 50 g of carbohydrate raised blood glucose and insulin by amounts that did not differ significantly from dextrose, even for a syrup with under 10% simple sugars. A tracer study also found glucose and insulin rose within 30 minutes. People counting carbohydrates should count IMO.

Slower stomach emptying than maltodextrin in a yogurt meal

In a randomized crossover trial in 20 adults, a yogurt carrying 26 g of IMO emptied from the stomach moderately but significantly more slowly than one with rapidly digested maltodextrin, consistent with IMO being digested slowly along the small intestine. About half of participants responded, and appetite ratings did not differ.

Blood cholesterol in small studies

In 13 older adults, total and LDL cholesterol were lower during 10 g/day IMO than during a placebo period, without randomization. In 20 hemodialysis patients, 30 g/day was reported to lower total cholesterol and triglycerides, but the FDA found LDL cholesterol did not differ from controls and judged the evidence inconsistent, noting no effect in a trial in healthy adults.

Digestive tolerance at large single servings

A single serving of IMO syrup giving 50 g of carbohydrate caused no more gastrointestinal symptoms or breath hydrogen than dextrose in 26 healthy adults. In a 1-week crossover, bloating or gas was reported by 25% of women on 15 g/day of an IMO product against 48% on inulin. An EU safety review accepted tolerability at up to 120 g/day.

Mechanism of action

1

Digested by small intestinal enzymes

The sucrase-isomaltase enzyme on the lining of the small intestine can split alpha-1,6 bonds. In lab tests, recombinant human sucrase-isomaltase broke IMOs down fully to glucose, only more slowly than linear malto-oligosaccharides, and breath hydrogen after IMO was a small fraction of that after FOS, showing little reached the colon.

2

A smaller fraction fermented in the colon

A tracer study estimated that part of IMO is digested and the rest fermented by gut bacteria, giving an energy value of about 75% of maltose. In studies of older adults, fecal acetate and propionate rose during IMO intake, a sign that some IMO reached colonic bacteria.

3

Slow digestion and the ileal brake

Because IMO is digested slowly, some of it can reach the lower small intestine, which is thought to trigger the ileal brake, a feedback signal that slows stomach emptying. A crossover trial found modestly slower stomach emptying after IMO, without a change in appetite ratings.

4

Why lab fiber tests can overstate IMO fiber

Standard fiber assays use a fungal enzyme that barely cuts alpha-1,6 bonds, so IMO can test as fiber in the lab even though human intestinal enzymes digest it. An industry survey of commercial IMO ingredients reported that likely glycemic impact may not match fiber claims on labels.

Clinical trials

1
Blood glucose and insulin after IMO syrup versus dextrose
PubMed

Two randomized, double-blind crossover studies; single doses of IMO syrup matched to 50 g of carbohydrate against 50 g of dextrose; study 1 measured glucose, insulin and breath hydrogen over 4 to 24 hours, study 2 measured glucose over 2 hours. Written by employees of Ingredion, which made the syrups. (Gourineni et al. 2018, Nutrients)

Healthy adults: 26 in study 1 and 10 in study 2.

Glucose and insulin responses to IMO did not differ significantly from dextrose over 4 hours; glucose area was about 15% lower (p = 0.058), and lower only from 2 to 4 hours (p = 0.008). Breath hydrogen and symptom scores matched dextrose. In study 2, neither IMO syrup, including one with under 10% simple sugars, differed from dextrose (p = 0.662). The authors concluded IMO is digestible.

2
Breath hydrogen after IMO, FOS and galactosyl-sucrose
PubMed

Comparison study; 10 g and then 20 g of each oligosaccharide at 1-week intervals, with breath hydrogen measured for 7 hours. Funded by Siebold University of Nagasaki. (Oku et al. 2003, Eur J Clin Nutr)

Healthy young adults in Japan (9 men and 29 women took part).

After 10 g, breath hydrogen area was 9768 ppm with FOS, 3662 ppm with galactosyl-sucrose and 831 ppm with IMO. The authors concluded IMO was readily hydrolyzed by small intestinal enzymes, so little reached the colon for fermentation.

3
Bowel habits in older men on a low-fiber diet
PubMed

Before-and-after study without randomization or blinding; 30-day low-fiber control period, then 30 days of 10 g/day IMO active components. (Chen et al. 2001, J Am Coll Nutr)

7 older men with constipation in Taiwan.

During the IMO period, defecation frequency doubled, wet stool output rose 70% and dry stool weight 55%, mostly from bacterial mass, and fecal acetate and propionate rose. Enemas were allowed during the study, and the FDA later found the independent effect of IMO could not be evaluated.

4
Gut bacteria, bowel function and cholesterol over 8 weeks in older adults
PubMed

Diet-controlled study in the same people without randomization: 4-week placebo period, two 4-week periods of 10 g/day IMO, then 4 weeks off IMO. (Yen et al. 2011, Nutrition)

13 constipated older adults (mean age 82.5) in Taiwan.

Fecal bifidobacteria, lactobacilli and bacteroides rose and clostridia fell; wet fecal mass rose 24% and spontaneous defecation rose in the second IMO period only. Total and LDL cholesterol were lower than in the placebo or post period. Effects faded after IMO stopped. Enemas were allowed, and the FDA called the cholesterol results inconsistent across comparisons.

5
Bifidobacteria screening of seven carbohydrates
PubMed

Double-blind, randomized, placebo-controlled parallel-group screening phase; 10 g/day of each carbohydrate or placebo for 7 days, 8 people per group. (Bouhnik et al. 2004, Am J Clin Nutr)

Healthy volunteers in France.

IMO did not raise fecal bifidobacteria, nor did lactulose or long-chain inulin, while short-chain FOS, soybean oligosaccharides, galacto-oligosaccharides and resistant starch did. IMO was not taken into the dose-response phase.

6
Vitafiber IMO compared with inulin and a fiber blend
PubMed

Crossover study without a placebo; 15 g/day of Vitafiber IMO, inulin or a fiber blend for 1 week each, with 2-week washouts. Funded by Australian public research grants. (Tan et al. 2023, Gut Microbes)

Healthy women aged 30 to 65 (34 enrolled, 28 completed).

Vitafiber did not change gut microbiota diversity or any bacterial phylum, and post-Vitafiber samples could not be told apart from baseline; the authors wrote it had the least effect of the three on microbiota, short-chain fatty acids and immune phenotypes. Bloating or gas was reported by 25% on Vitafiber and 48% on inulin.

7
Stomach emptying after IMO in a yogurt meal
PubMed

Five-arm randomized, double-blind crossover trial; yogurts with 26 g of IMO, raw corn starch, sucromalt, an IMO and sucromalt mix, or maltodextrin; outcomes over 4 hours. Several authors employed by General Mills; registered retrospectively as NCT03630445. (Chegeni et al. 2022, Eur J Nutr)

20 adults (9 women, 11 men).

Gastric half-emptying time was moderately but significantly longer with IMO and with raw corn starch than with maltodextrin, with about half of participants responding. Appetite ratings did not differ. The trial treated IMO as a slowly digestible carbohydrate.

Side effects and drug interactions

Common Potential side effects

IMO supplies digestible carbohydrate: in crossover tests in healthy adults, blood glucose and insulin rose about as much as after the same amount of dextrose.
Commercial syrups can also contain large amounts of glucose and maltose; one tested syrup was 40% mono- and disaccharides.
Gas or bloating can occur; 25% of healthy women reported bloating or gas on 15 g/day for 1 week, fewer than on inulin.
A 50 g carbohydrate serving caused no more digestive symptoms than dextrose in 26 healthy adults, and an EU safety review accepted tolerability at up to 120 g/day.
Some gastrointestinal side effects, described as well tolerated, were reported at 30 g/day in hemodialysis patients.

Important Drug interactions

No drug interaction studies of IMO were found.
Insulin and other glucose-lowering medicines: IMO raised blood glucose about as much as dextrose in tests, so count it as carbohydrate and ask your prescriber before relying on IMO-sweetened products as low-sugar.
People on low-carbohydrate or ketogenic diets should count IMO as digestible carbohydrate rather than fiber.
People on dialysis or with serious digestive conditions should ask their care team before adding concentrated fiber or sweetener products.

Frequently asked questions about Isomalto-Oligosaccharides (IMO)

Is IMO a dietary fiber?

It depends on the country. The FDA denied petitions to add IMO to its dietary fiber list in 2018 and again in January 2020, finding the evidence did not show a beneficial physiological effect, and IMO is not on FDA's list of added fibers. Health Canada accepts isomaltooligosaccharides as a novel fiber. Human studies show much of IMO is digested like a slow sugar.

Does IMO raise blood sugar?

Yes. In randomized crossover tests in healthy adults, IMO syrups matched to 50 g of carbohydrate raised blood glucose and insulin by amounts that did not differ significantly from dextrose. Treat IMO as digestible carbohydrate, especially if you manage your blood sugar or follow a low-carbohydrate diet.

What is IMO made from, and where is it used?

IMO is made from corn or tapioca starch with enzymes, giving short glucose chains such as isomaltose and panose along with some glucose and maltose. It is sold as a syrup or powder sweetener and bulking agent in protein bars, shakes and low-sugar foods. VitaFiber® (Isomalto-Oligosaccharide) is one branded form.

How much IMO has been studied, and is it safe?

Studies used 10 g/day for 30 days to 8 weeks in older adults, 15 g/day for 1 week in healthy women, 30 g/day in hemodialysis patients, and 36 or 54 g/day for 4 weeks in an unpublished trial in healthy adults. FDA had no questions on several GRAS notices for IMO in foods, and an EU safety review accepted tolerability at up to 120 g/day. Gas and bloating are possible.

What is Isomalto-Oligosaccharides?

Isomalto-oligosaccharides (IMO) are short chains of glucose joined mainly by alpha-1,6 bonds, such as isomaltose, isomaltotriose and panose, made from corn or tapioca starch with enzymes and sold as a syrup or powder sweetener and bulking agent.

What is Isomalto-Oligosaccharides used for?

NutraSmarts does not list Isomalto-Oligosaccharides under a health category. What the research covers: In 7 older men, 10 g/day for 30 days doubled defecation frequency and raised wet stool output 70% against a prior low-fiber period, and in 13 older adults wet fecal mass rose 24% over a placebo period.

What is the recommended dosage of Isomalto-Oligosaccharides?

The clinically studied dose is 10 g/day for 30 days to 8 weeks in older adults; 30 g/day for 4 weeks in hemodialysis patients; 36 or 54 g/day for 4 weeks in an unpublished trial in healthy adults; 10 g/day for 7 days and 15 g/day for 1 week in microbiome studies; single doses of syrup givin… Always follow the product label and check with a healthcare provider for personal advice.

Is Isomalto-Oligosaccharides safe, and does it have side effects?

Side effects and cautions reported for Isomalto-Oligosaccharides include: IMO supplies digestible carbohydrate: in crossover tests in healthy adults, blood glucose and insulin rose about as much as after the same amount of dextrose. It may also interact with some medications. Isomalto-Oligosaccharides is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Isomalto-Oligosaccharides interact with any medications?

Possible interactions include: No drug interaction studies of IMO were found. Insulin and other glucose-lowering medicines: IMO raised blood glucose about as much as dextrose in tests, so count it as carbohydrate and ask your prescriber before relying on IMO-sweetened products as low-sugar. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Isomalto-Oligosaccharides?

NutraSmarts rates the evidence for Isomalto-Oligosaccharides as Limited (2 out of 5). It is backed by 7 study summaries and 17 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(17 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Gourineni V, Stewart ML, Icoz D, Zimmer JP. Gastrointestinal Tolerance and Glycemic Response of Isomaltooligosaccharides in Healthy Adults. Nutrients. 2018;10(3):301. doi: 10.3390/nu10030301.PubMedUsed to support: Two randomized, double-blind crossover studies of IMO syrups made by Ingredion, whose employees wrote the paper. In 26 healthy adults, an IMO syrup giving 50 g of carbohydrate produced blood glucose and insulin responses over 4 hours that did not differ significantly from 50 g of dextrose; glucose area was about 15% lower over 4 hours (p = 0.058) and lower only in the 2 to 4 hour window (p = 0.008). Breath hydrogen and gastrointestinal symptom scores did not differ from dextrose. In 10 adults, the 2-hour glucose response to two IMO syrups, one with 70% IMO and under 10% simple sugars, did not differ from dextrose (p = 0.662). The authors concluded IMO is digestible.
  2. Oku T, Nakamura S. Comparison of digestibility and breath hydrogen gas excretion of fructo-oligosaccharide, galactosyl-sucrose, and isomalto-oligosaccharide in healthy human subjects. Eur J Clin Nutr. 2003;57(9):1150-6. doi: 10.1038/sj.ejcn.1601666.PubMedUsed to support: Breath hydrogen study in healthy young Japanese adults (9 men and 29 women took part) given 10 g and then 20 g of each oligosaccharide. After 10 g, breath hydrogen area was 9768 ppm for FOS, 3662 ppm for galactosyl-sucrose and 831 ppm for IMO. The authors concluded that FOS was not hydrolyzed in the small intestine while IMO was readily hydrolyzed by small intestinal enzymes, so little of it reached the colon to be fermented. Funded by Siebold University of Nagasaki.
  3. Kohmoto T, Tsuji K, Kaneko T, Shiota M, Fukui F, Takaku H, Nakagawa Y, Ichikawa T, Kobayash S. Metabolism of (13)C-Isomaltooligosaccharides in Healthy Men. Biosci Biotechnol Biochem. 1992;56(6):937-40. doi: 10.1271/bbb.56.937.PubMedUsed to support: Tracer study in six healthy men by researchers from Showa Sangyo, an IMO producer, with a public institute. Serum glucose and insulin rose 30 minutes after carbon-13 labeled IMO, and labeled carbon dioxide recovery in breath was 70 to 80% of that after maltose. The authors concluded that part of IMO is digested and the rest is fermented by gut bacteria, and estimated its energy value at about 75% of maltose.
  4. Chegeni M, Hayes AMR, Gonzalez TD, Manderfeld MM, Lim J, Menon RS, Holschuh NM, Hedges ME, Hamaker BR. Activation of gastrointestinal ileal brake response with dietary slowly digestible carbohydrates, with no observed effect on subjective appetite, in an acute randomized, double-blind, crossover trial. Eur J Nutr. 2022;61(4):1965-1980. doi: 10.1007/s00394-021-02770-2.PubMedUsed to support: Five-arm randomized, double-blind crossover trial in 20 adults, retrospectively registered as NCT03630445, with several authors employed by General Mills. Yogurts carrying 26 g of raw corn starch, IMO, sucromalt, an IMO and sucromalt mix, or rapidly digested maltodextrin were matched for energy and thickness. IMO is treated here as a slowly digestible carbohydrate, not a fiber. Gastric half-emptying time was moderately but significantly longer with raw corn starch and IMO, with about half of participants responding, and appetite ratings did not differ between treatments.
  5. Song YB, Lamothe LM, Esmeralda Nava Rodriguez N, Rose DR, Lee BH. New insights suggest isomaltooligosaccharides are slowly digestible carbohydrates, rather than dietary fibers, at constitutive mammalian α-glucosidase levels. Food Chem. 2022;383:132456. doi: 10.1016/j.foodchem.2022.132456.PubMedUsed to support: Laboratory enzyme study, not a human trial, with one author from Nestle Research. Small intestinal alpha-glucosidases from rat and recombinant human sucrase-isomaltase fully broke various IMOs down to glucose, though more slowly than linear malto-oligosaccharides, while the fungal amyloglucosidase used in standard assays could not, because it barely acts on alpha-1,6 bonds. The authors concluded IMOs have been misjudged as prebiotics that bypass the small intestine and behave as slowly digestible carbohydrates rather than dietary fibers.
  6. Madsen LR 2nd, Stanley S, Swann P, Oswald J. A Survey of Commercially Available Isomaltooligosaccharide-Based Food Ingredients. J Food Sci. 2017;82(2):401-408. doi: 10.1111/1750-3841.13623.PubMedUsed to support: Laboratory analysis of 7 commercial IMO bulk ingredients by authors employed by ISOThrive, which sells a fermentation-made IMO product. It distinguishes IMO made from starch with alpha-glucosidase (industrial IMO) from IMO made by bacterial fermentation of sucrose, and concludes that the digestibility and likely glycemic impact of industrial IMO may not match product labels and certificates of analysis on fiber content, prebiotic fiber content and glycemic response. It notes IMO is marketed in bars and shakes at more than 15 g per serving.
  7. Chen HL, Lu YH, Lin JJ, Ko LY. Effects of isomalto-oligosaccharides on bowel functions and indicators of nutritional status in constipated elderly men. J Am Coll Nutr. 2001;20(1):44-9. doi: 10.1080/07315724.2001.10719013.PubMedUsed to support: Study in 7 older men in Taiwan with a 30-day low-fiber control period followed by a 30-day period with 10 g/day of IMO active components, with no randomization or blinding. During the IMO period, defecation frequency doubled, wet stool output rose 70% and dry stool weight 55%, mainly from added bacterial mass, and fecal acetate and propionate rose. Serum sodium fell; other blood measures did not change. The FDA later found that enema and laxative use during stool collection meant the independent effect of IMO could not be judged.
  8. Yen CH, Tseng YH, Kuo YW, Lee MC, Chen HL. Long-term supplementation of isomalto-oligosaccharides improved colonic microflora profile, bowel function, and blood cholesterol levels in constipated elderly people--a placebo-controlled, diet-controlled trial. Nutrition. 2011;27(4):445-50. doi: 10.1016/j.nut.2010.05.012.PubMedUsed to support: Study in 13 constipated older adults (mean age 82.5) on a controlled low-fiber diet: a 4-week placebo period, then two 4-week periods of 10 g/day IMO, then a 4-week period off IMO, in the same people without randomization. Fecal bifidobacteria, lactobacilli and bacteroides counts rose and clostridia fell, wet fecal mass rose 24%, spontaneous defecation rose only in the second IMO period, and total and LDL cholesterol were lower than in the placebo or post period. Effects faded after IMO stopped. The FDA later noted enemas were allowed and judged the cholesterol results inconsistent across comparisons.
  9. Wang HF, Lim PS, Kao MD, Chan EC, Lin LC, Wang NP. Use of isomalto-oligosaccharide in the treatment of lipid profiles and constipation in hemodialysis patients. J Ren Nutr. 2001;11(2):73-9. doi: 10.1016/s1051-2276(01)92591-9.PubMedUsed to support: Study in 20 patients on hemodialysis in Taiwan given 30 g/day of IMO for 4 weeks after a 2-week baseline; the abstract reports comparisons with baseline and with controls but does not say whether allocation was random. The authors reported more bowel movements, some well tolerated gastrointestinal side effects, lower total cholesterol and triglycerides and higher HDL cholesterol. In its 2020 review the FDA found baseline comparisons for total cholesterol were not reported and LDL cholesterol did not differ from the control group after 4 weeks. Results in dialysis patients may not apply to other people.
  10. Bouhnik Y, Raskine L, Simoneau G, Vicaut E, Neut C, Flourié B, Brouns F, Bornet FR. The capacity of nondigestible carbohydrates to stimulate fecal bifidobacteria in healthy humans: a double-blind, randomized, placebo-controlled, parallel-group, dose-response relation study. Am J Clin Nutr. 2004;80(6):1658-64. doi: 10.1093/ajcn/80.6.1658.PubMedUsed to support: Double-blind randomized placebo-controlled screening of 7 carbohydrates in healthy volunteers, 8 per group, each at 10 g/day for 7 days. Short-chain FOS, soybean oligosaccharides, galacto-oligosaccharides and type III resistant starch raised fecal bifidobacteria; IMO, lactulose and long-chain inulin did not. IMO was therefore not carried into the dose-response phase.
  11. Tan J, Ribeiro RV, Barker C, Daien C, De Abreu Silveira E, Holmes A, Nanan R, Simpson SJ, Macia L. Functional profiling of gut microbial and immune responses toward different types of dietary fiber: a step toward personalized dietary interventions. Gut Microbes. 2023;15(2):2274127. doi: 10.1080/19490976.2023.2274127.PubMedUsed to support: Crossover study without a placebo in healthy women aged 30 to 65 (34 enrolled, 28 completed), funded by Australian public research grants. Each woman took 15 g/day of Vitafiber IMO (bought from Myprotein), inulin, or a fiber blend for 1 week, with 2-week washouts. Vitafiber had no effect on gut microbiota diversity or on any bacterial phylum, and a statistical model could not tell post-Vitafiber samples from baseline; the authors wrote it had the least impact of the three on microbiota, short-chain fatty acids and immune phenotypes. Bloating or gas was reported by 25% on Vitafiber versus 48% on inulin.
  12. EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, Siskos A, van Loveren H, Albert O, Knutsen HK. Extension of use of isomalto-oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 2024;22(2):e8543. doi: 10.2903/j.efsa.2024.8543.PubMedUsed to support: EU food safety opinion on extending the uses of an already authorized IMO novel food, described as glucose oligomers with 3 to 9 units plus varying amounts of mono- and disaccharides, sold as syrup or powder, including use in food supplements for people over 10 years old. A tolerability study in adults supported tolerability at doses up to 120 g/day, and the panel concluded the proposed uses raise no safety concerns. It is a safety assessment, not evidence of a health benefit.
  13. U.S. Food and Drug Administration, Office of Nutrition and Food Labeling. Final response letter from FDA to BioNeutra North America Inc, Docket FDA-2019-P-2239 (citizen petition to add isomaltooligosaccharides to the dietary fiber definition) FDA citizen petition response (regulations.gov). 2020;Letter dated January 9, 2020; posted January 13, 2020..SourceUsed to support: Not PubMed-indexed. The official regulations.gov file returned an access error and has no archived copy, so the letter was read in 2026 from a scanned copy posted by a third party; the docket entry, title and January 13, 2020 posting date were confirmed through the regulations.gov API, and the official document URL is cited. FDA denied BioNeutra's May 3, 2019 petition to add IMO to the list of dietary fibers in 21 CFR 101.9(c)(6)(i), noting it had denied BioNeutra's first petition (Docket FDA-2016-P-4275) on June 13, 2018. FDA concluded that the strength of the evidence does not show that consuming IMO has a physiological effect that is beneficial to human health, for laxation or for blood cholesterol. It could not draw conclusions from the Chen 2001 and Yen 2011 studies because enemas and laxatives were used, and found the cholesterol studies inconsistent, including a null result in healthy Canadian adults. FDA said it does not plan to propose adding IMO and would consider a new petition based on new science.
  14. U.S. Food and Drug Administration. Questions and Answers on Dietary Fiber FDA web page. 2024;Content current as of 07/25/2024; accessed 2026..SourceUsed to support: Not PubMed-indexed; FDA web page read in 2026. Lists the 7 non-digestible carbohydrates in the 2016 dietary fiber definition and those FDA has said it will treat as dietary fiber: the 8 covered by its June 2018 guidance (mixtures of plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch, galactooligosaccharide, polydextrose, resistant maltodextrin/dextrin), plus cross-linked phosphorylated RS4 (2019), glucomannan (2020) and acacia gum (2021). Isomaltooligosaccharide does not appear on the page.
  15. Health Canada, Food Directorate. List of Dietary Fibres Reviewed and Accepted by Health Canada's Food Directorate Health Canada publication. 2021;Updated June 2021; accessed 2026..SourceUsed to support: Not PubMed-indexed; Health Canada list read in 2026. Table 1, under oligosaccharides, lists isomaltooligosaccharides as a mixture of glucose oligomers enzymatically produced from edible starch and modified by transglycosylation, mostly 3 to 6 glucose units. The stated reason for acceptance is novel fiber providing energy-yielding metabolites. No manufacturer or product is named.
  16. U.S. Food and Drug Administration. GRAS Notices inventory: search results for isomalto FDA GRAS Notice Inventory. 2026;Accessed November 2026..SourceUsed to support: Not PubMed-indexed; FDA inventory read in 2026. FDA had no questions on isomalto-oligosaccharide notices GRN 246 (BioNeutra, closed February 10, 2009, for foods at 1.5 to 15 g per serving; a resubmission of GRN 172, which FDA stopped evaluating at the notifier's request), GRN 674 (July 5, 2017), GRN 779 (Baolingbao Biology, October 19, 2018) and GRN 818 (December 18, 2019). GRAS status concerns safe use in food, not health benefits or fiber status.
  17. U.S. Food and Drug Administration, Office of Nutrition and Food Labeling. Letter from FDA CFSAN to BioNeutra North America Inc: denial response, Docket FDA-2016-P-4275 (citizen petition to add isomalto-oligosaccharides to the dietary fiber definition) FDA citizen petition response (regulations.gov). 2018;Letter dated June 13, 2018; posted June 14, 2018..SourceUsed to support: Not PubMed-indexed; FDA letter read in 2026 from the official regulations.gov file as captured by the Internet Archive on May 31, 2024. FDA denied BioNeutra's December 5, 2016 petition, concluding that the strength of the evidence does not show that consuming IMO has a physiological effect that is beneficial to human health. It drew no laxation conclusions from Chen 2001 and Yen 2011 because subjects could use enemas during fecal collection. In an unpublished 4-week double-blind, randomized, placebo-controlled BioNeutra study of VitaSugar/VitaFiber IMO in healthy adults (19 per group; 36 or 54 g/day against dextrose), bowel movements per day did not differ from control, and Bouhnik 2004 found no effect of IMO on stool number. Across the three studies FDA could assess, 10 of 12 comparisons showed no significant effect on laxation.