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GeniVida® (Synthetic Genistein — DSM)

Evidence Level
Moderate
4 Clinical Trials
3 Documented Benefits
3/5 Evidence Score

GeniVida® is a purified genistein, an isoflavone found in soy, made by DSM through a patented process rather than extracted from soy. Genistein is a plant estrogen, a plant compound with estrogen-like action. In a 12-week placebo-controlled trial that DSM announced as a GeniVida study, 84 postmenopausal women took 30 mg of GeniVida a day; hot flush frequency fell by about half, against about a quarter with placebo. A meta-analysis of 17 trials found that extracted or synthesized soy isoflavones reduced hot flash frequency and severity, while a Cochrane review judged the overall phytoestrogen evidence inconclusive but noted consistent results for higher-dose genistein. For bone, a 2-year trial of 54 mg/day genistein aglycone in 389 women with low bone density increased spine and hip bone density, though that study did not use GeniVida specifically.

Studied Dose 30 mg/day of GeniVida for 12 weeks for hot flushes, or 30 mg/day within a combination for 6 months for bone. 54 mg/day of genistein aglycone, not specifically GeniVida, for 2 to 3 years in the main bone trials.
Active Compound Genistein (aglycone), produced by synthesis rather than soy extraction, according to the supplier.

Benefits

Hot flush frequency in postmenopausal women

In a 12-week placebo-controlled trial, 30 mg/day of GeniVida cut daily hot flushes by 51%, from 9.4 to 4.7, against 27% with placebo, and shortened them. Menopause symptom scores and hormone levels did not differ. Pooled results from soy isoflavone trials also show fewer and milder hot flashes.

Supported by Trial 1

Bone density after menopause

In a 2-year trial in 389 women with low bone density, 54 mg/day of genistein aglycone with calcium and vitamin D raised spine and hip bone density, while it fell on placebo. In a 6-month trial, a GeniVida blend with vitamins D3 and K1 and omega-3s maintained hip bone density.

Supported by Trial 4, Trial 2

Plant estrogen activity

Genistein is a phytoestrogen with estrogen-like action. In the 2- and 3-year bone trials, it did not change endometrial thickness, and after 3 years breast density did not differ from placebo.

Supported by Trial 3, Trial 2

Mechanism of action

1

Estrogen receptor binding

Genistein is a phytoestrogen, a plant compound with estrogen-like action. This is the basis for studying it for menopausal hot flushes and for bone health after menopause.

2

Bone turnover markers

In the 2-year trial, genistein lowered urinary markers of bone breakdown and raised blood markers of bone formation compared with placebo, consistent with the bone density results.

Clinical trials

1
GeniVida for hot flushes in postmenopausal women
PubMed

12-week multicentre randomized double-blind placebo-controlled trial of 30 mg/day synthetic genistein. Run by a contract research company; DSM, the maker, announced it as a study of GeniVida. (Evans et al. 2011, Maturitas)

84 healthy postmenopausal women.

In the 40 women on genistein completing at least 4 weeks, daily hot flushes fell by 51% (9.4 to 4.7) with genistein vs 27% (9.9 to 7.1) with placebo, and total daily hot flush duration fell. Greene Climacteric Scale scores, FSH, estradiol, endometrial thickness and adverse events did not differ.

2
Genistein aglycone and bone in postmenopausal women with low bone density
PubMed

24-month randomized double-blind placebo-controlled trial at 3 Italian university centres. 54 mg/day genistein aglycone; both groups also received calcium and vitamin D. Not specifically GeniVida. (Marini et al. 2007, Ann Intern Med)

389 postmenopausal women with low femoral neck bone density: 198 on genistein, 191 on placebo.

Spine and hip bone density rose on genistein and fell on placebo (differences 0.10 and 0.062 g/cm2). Bone breakdown markers fell and formation markers rose. Endometrial thickness did not change. Digestive side effects were more common with genistein (19% vs 8%). Fractures were not measured.

3
Genistein aglycone: 3-year bone and breast follow-up
PubMed

Third-year extension of the 2-year trial in a subgroup, 54 mg/day genistein aglycone or placebo with calcium and vitamin D. (Marini et al. 2008, J Clin Endocrinol Metab)

138 women from the original trial: 71 on genistein, 67 on placebo.

After 36 months, bone density gains were greater with genistein at spine and hip. Mammographic breast density and endometrial thickness did not change significantly, and discomfort and adverse events did not differ between groups.

4
GeniVida bone blend in early postmenopausal women: pilot trial
PubMed

6-month randomized double-blind pilot trial of 30 mg/day genistein with vitamin D3, vitamin K1 and omega-3 fatty acids vs calcium only. Four authors are DSM employees. (Lappe et al. 2013, Eur J Nutr)

70 early postmenopausal women randomized; 30 on the blend and 28 controls analysed.

Femoral neck bone density was maintained with the blend and fell in controls, and Ward's triangle density differed in favour of the blend. Because genistein was combined with other nutrients, its own effect cannot be separated. Adverse events did not differ.

Side effects and drug interactions

Common Potential side effects

Digestive side effects such as stomach upset were more common with 54 mg/day genistein than placebo in the 2-year bone trial (19% vs 8%).
At 30 mg/day for 12 weeks, adverse events did not differ from placebo.
Over 3 years, breast density and endometrial thickness did not change significantly with 54 mg/day in women with low bone density.

Important Drug interactions

Women with a history of breast or other hormone-sensitive cancer, or taking tamoxifen, aromatase inhibitors or hormone therapy, should talk to their doctor before using a plant estrogen; these combinations have not been studied in genistein trials.
People taking thyroid medicine or other prescription medicines should ask a doctor or pharmacist before use.

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Frequently asked questions about GeniVida® (Synthetic Genistein — DSM)

What is GeniVida?

GeniVida® is a purified genistein, an isoflavone found in soy, made by DSM through a patented process rather than extracted from soy. Genistein is a plant estrogen, a plant compound with estrogen-like action.

What is GeniVida used for?

GeniVida is researched primarily for Women's Health, Menopause Support, and Bone Health. In a 12-week placebo-controlled trial, 30 mg/day of GeniVida cut daily hot flushes by 51%, from 9.4 to 4.7, against 27% with placebo, and shortened them. Menopause symptom scores and hormone levels did not differ.

What is the recommended dosage of GeniVida?

The clinically studied dose is 30 mg/day of GeniVida for 12 weeks for hot flushes, or 30 mg/day within a combination for 6 months for bone. 54 mg/day of genistein aglycone, not specifically GeniVida, for 2 to 3 years in the main bone trials. Always follow the product label and check with a healthcare provider for personal advice.

Is GeniVida safe, and does it have side effects?

Side effects and cautions reported for GeniVida include: Digestive side effects such as stomach upset were more common with 54 mg/day genistein than placebo in the 2-year bone trial (19% vs 8%). At 30 mg/day for 12 weeks, adverse events did not differ from placebo. It may also interact with some medications. GeniVida 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 GeniVida interact with any medications?

Possible interactions include: Women with a history of breast or other hormone-sensitive cancer, or taking tamoxifen, aromatase inhibitors or hormone therapy, should talk to their doctor before using a plant estrogen; these combinations have not been studied in genistein trials. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for GeniVida?

NutraSmarts rates the evidence for GeniVida as Moderate (3 out of 5). It is backed by 4 study summaries and 8 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(8 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. Evans M, Elliott JG, Sharma P, Berman R, Guthrie N. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: a multi-center, randomized, placebo-controlled study. Maturitas. 2011;68(2):189-96. doi: 10.1016/j.maturitas.2010.11.012.PubMedUsed to support: 12-week randomized double-blind placebo-controlled trial in 84 postmenopausal women given 30 mg/day synthetic genistein (announced by DSM as its GeniVida). Daily hot flushes fell by 51% vs 27% with placebo in women completing at least 4 weeks, with shorter hot flushes; menopause scale scores, hormones, endometrial thickness and adverse events did not differ.
  2. Taku K, Melby MK, Kronenberg F, Kurzer MS, Messina M. Extracted or synthesized soybean isoflavones reduce menopausal hot flash frequency and severity: systematic review and meta-analysis of randomized controlled trials. Menopause. 2012;19(7):776-90. doi: 10.1097/gme.0b013e3182410159.PubMedUsed to support: Meta-analysis of 17 randomized trials: soy isoflavones, extracted or synthesized (median 54 mg/day for 6 weeks to 12 months), reduced hot flash frequency by 20.6% and severity by 26.2% compared with placebo, with substantial heterogeneity. Supplements with more than 18.8 mg genistein were more than twice as effective on frequency as lower-genistein ones.
  3. Lethaby A, Marjoribanks J, Kronenberg F, Roberts H, Eden J, Brown J. Phytoestrogens for menopausal vasomotor symptoms. Cochrane Database Syst Rev. 2013;2013(12):CD001395. doi: 10.1002/14651858.CD001395.pub4.PubMedUsed to support: Cochrane review of 43 randomized trials (4,364 women) of phytoestrogens for hot flushes and night sweats. Overall it found no conclusive evidence of benefit, noted a strong placebo effect, and reported that four trials of extracts with more than 30 mg/day genistein consistently reduced hot flush frequency. No endometrial stimulation or other harms were found for up to 2 years.
  4. Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.PubMedUsed to support: 24-month randomized double-blind placebo-controlled trial in 389 postmenopausal women with low bone density. Genistein aglycone 54 mg/day with calcium and vitamin D raised spine and hip bone density while it fell on placebo, and improved bone turnover markers. Gastrointestinal side effects were more common (19% vs 8%). Fractures were not measured.
  5. Marini H, Bitto A, Altavilla D, Burnett BP, Polito F, Di Stefano V, Minutoli L, Atteritano M, Levy RM, D'Anna R, Frisina N, Mazzaferro S, Cancellieri F, Cannata ML, Corrado F, Frisina A, Adamo V, Lubrano C, Sansotta C, Marini R, Adamo EB, Squadrito F. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab. 2008;93(12):4787-96. doi: 10.1210/jc.2008-1087.PubMedUsed to support: One-year extension in 138 women from the 2-year genistein aglycone trial. After 36 months, genistein did not significantly change breast density or endometrial thickness, bone density gains remained greater than placebo, and adverse events did not differ.
  6. Lappe J, Kunz I, Bendik I, Prudence K, Weber P, Recker R, Heaney RP. Effect of a combination of genistein, polyunsaturated fatty acids and vitamins D3 and K1 on bone mineral density in postmenopausal women: a randomized, placebo-controlled, double-blind pilot study. Eur J Nutr. 2013;52(1):203-215. doi: 10.1007/s00394-012-0304-x.PubMedUsed to support: 6-month randomized double-blind pilot trial in 70 early postmenopausal women: a geniVida bone blend (30 mg/day synthetic genistein made by DSM, with vitamins D3 and K1 and omega-3 fatty acids) maintained femoral neck bone density while it fell with calcium alone. Four authors are DSM employees.
  7. SupplySide Supplement Journal. DSM's geniVida Affirmed GRAS SupplySide Supplement Journal (trade news). 2010;July 2010..SourceUsed to support: Trade news item, not PubMed-indexed. It describes geniVida from DSM Nutritional Products as a soy-free, allergen-free, non-GMO genistein made by a patented process and self-affirmed GRAS for selected foods and beverages.
  8. Nutraceuticals World. geniVida Reduces Hot Flashes and Night Sweats Nutraceuticals World (trade news). 2010;October 20, 2010..SourceUsed to support: Trade news item, not PubMed-indexed. It reports that geniVida genistein from DSM Nutritional Products was tested with KGK Synergize in a randomized double-blind placebo-controlled trial of 84 healthy postmenopausal women, with a 51% reduction in hot flashes after 12 weeks against 27% on placebo. It links the Evans trial to GeniVida.