DeltaGold® (Annatto Tocotrienols — American River Nutrition)

Bixa orellana
Evidence Level
Limited
3 Clinical Trials
8 Documented Benefits
2/5 Evidence Score

DeltaGold® is the first and only tocopherol-free tocotrienol ingredient from American River Nutrition (Everwell Health subsidiary) — derived from annatto plant (Bixa orellana). Distinguished by ~90% delta + 10% gamma tocotrienol composition with NO interfering tocopherols. GRAS is a safety determination for food use that a manufacturer self-affirms or supports with a notice to FDA; FDA does not grant or award GRAS status. Note what the references on this page actually cover. The only annatto-specific human evidence here is a single cohort of 89 postmenopausal osteopenic women reported in two papers, which found changes in bone turnover and oxidative stress markers but no significant differences in the other outcomes it measured. Two of the five references used different tocotrienol sources, rice bran and mixed palm. A pooled analysis of tocotrienol trials found no significant change in total or LDL cholesterol.

Studied Dose 430 or 860 mg/day annatto extract (roughly 300 or 600 mg/day tocotrienol) in the 12-week bone marker trial; the quoted 250 mg/day figure comes from a diabetes trial not cited here.
Active Compound Annatto-derived tocotrienols (~90% delta-T3 + 10% gamma-T3, tocopherol-free)

Benefits

Diabetes Trial Claim With No Citation On This Page

This page previously reported a 24-week trial of 250 mg/day in 110 people with type 2 diabetes, with specific figures for fasting glucose, HbA1c, insulin and HOMA-IR. That trial is not among the five references listed here, so none of those numbers can be checked against a source and they should not be relied on. Type 2 diabetes is a diagnosed disease, a dietary supplement is not a treatment for it, and blood sugar management belongs with a physician.

Cardiovascular Health

The cholesterol claim previously made here does not survive the meta-analysis this page cites. Pooling 15 randomized trials of tocotrienols across 20 arms, total cholesterol did not change significantly (+0.010 mmol/L) and LDL cholesterol did not change significantly either (+0.095 mmol/L). Note the signs: both moved numerically upward, not down. Triglycerides were also not significant overall (-0.112 mmol/L) and fell significantly only in arms using 200 mg/day or more (-0.177 mmol/L). The one lipid that did move was HDL cholesterol, up 0.146 mmol/L. That analysis covers tocotrienols generally, not annatto DeltaGold specifically.

Comparative Potency Claim (Uncited)

No study cited on this page compared delta- or gamma-tocotrienol against alpha forms for any metabolic outcome, and the phrase established in multiple studies pointed to nothing a reader could check. Treat the comparative potency claim as unsupported here.

Bone Turnover Markers in Postmenopausal Osteopenic Women

This is the only annatto-specific evidence on the page. In 89 postmenopausal osteopenic women, 87 of whom completed, taking 430 or 860 mg/day of the annatto extract for 12 weeks, urinary NTX fell, soluble RANKL and the sRANKL/OPG ratio fell, the BALP/NTX ratio rose, and urinary 8-OHdG fell. Serum OPG and urinary calcium did not change. These are bone turnover and oxidative stress markers measured over 12 weeks. Neither bone mineral density nor fracture outcomes were measured, and the companion report from the same cohort found no significant differences in the other outcomes it assessed.

Tocopherol-free Distinction

Alpha-tocopherol has been reported to interfere with tocotrienol uptake, and DeltaGold contains no tocopherols. Note the tension this creates on this page. Two of the five references are the very sources this argument disqualifies: the 2002 lipid trial used a rice bran tocotrienol-rich fraction, and the 2013 liver trial used mixed palm tocotrienols. If tocopherol content makes those preparations a poor guide to what DeltaGold does, their results cannot also be counted as evidence for it. The page cannot have this both ways.

GRAS Food Status (Regulatory, Not a Health Benefit)

FDA does not grant, award or confer GRAS status. A company either self-affirms that an ingredient is generally recognized as safe or files a GRAS notice, to which FDA may respond with a letter stating it has no questions. That is a genuine regulatory step and it does support use in foods and beverages, but it is a safety determination about a food use, not evidence that the ingredient does anything.

Manufacturing Note (Not a Health Benefit)

Patented process and US-based production. This describes how and where the ingredient is made. It is a manufacturing and supply detail, not a health benefit, and says nothing about what the ingredient does in the body.

Triglycerides: What the Cited Evidence Shows

The 10.3 percent versus 0.9 percent figures came from the diabetes trial that is not cited on this page, so they cannot be verified. In the meta-analysis this page does cite, triglycerides did not fall significantly overall (-0.112 mmol/L). A significant reduction appeared only in the subset of arms dosing 200 mg/day or more (-0.177 mmol/L).

Mechanism of action

1

Delta- and Gamma-Tocotrienol Activity

Delta-tocotrienol has a less methylated chromanol ring than the alpha form, and all tocotrienols carry an unsaturated side chain. Both features are proposed to affect how these molecules sit in cell membranes. That is structural reasoning, not a measured outcome. No human study cited on this page compared delta-tocotrienol against alpha forms, so superiority in metabolic applications is not something this page can support.

2

HMG-CoA Reductase Modulation

Tocotrienols suppress HMG-CoA reductase, the same enzyme statins inhibit, though by a different route. This is a laboratory mechanism. In the pooled human data cited here, total and LDL cholesterol did not change significantly, so the mechanism should not be read as a demonstrated cholesterol-lowering effect in people.

3

miRNA Modulation (T2DM Trial)

The microRNA figures previously quoted here came from the diabetes trial that is not among this page's references, so they cannot be verified. No study cited on this page measured microRNA.

4

NF-kB Anti-Inflammatory

Delta- and gamma-tocotrienol have been shown in laboratory work to modulate the NF-kB pathway. The IL-6 and TNF-alpha percentages previously listed here came from the uncited diabetes trial. No reference on this page reports either marker.

5

Antioxidant Activity

The unsaturated side chain is thought to help tocotrienols distribute into tissue membranes. In the 12-week postmenopausal osteopenic cohort, urinary 8-OHdG, a marker of oxidative DNA damage, fell relative to placebo. Broader claims that tocotrienols out-scavenge tocopherols are not established by anything cited here.

6

No Interference from Alpha-Tocopherol

DeltaGold's tocopherol-free composition prevents alpha-tocopherol's interference with tocotrienol uptake and function.

Clinical trials

1
Diabetes Trial Described Here Without a Citation

UNCITED. A 24-week trial of 250 mg/day in 110 people with type 2 diabetes was described here, but it is not among the five references on this page and no source is given for it.

Reported as 110 people with type 2 diabetes. Not verifiable from any reference on this page.

No verifiable findings. The figures previously listed here for fasting glucose, HbA1c, insulin, HOMA-IR, triglycerides, LDL, IL-6, TNF-alpha and microRNA have no source on this page. Type 2 diabetes is a disease and this ingredient is not a treatment for it.

2
Annatto Tocotrienol and Bone Turnover Markers

12-week randomized double-blind placebo-controlled trial of annatto-derived tocotrienol at 90 percent delta and 10 percent gamma, 430 or 860 mg/day, reported in Osteoporos Int 2018 (PMID 29330573), with a companion safety and quality-of-life paper from the same cohort naming DeltaGold 70 (PMID 29954374).

89 postmenopausal osteopenic women enrolled, 87 completed.

Urinary NTX, soluble RANKL, the sRANKL/OPG ratio and urinary 8-OHdG fell, and the BALP/NTX ratio rose. Serum OPG and urinary calcium did not change. These are bone turnover and oxidative stress markers, not bone mineral density and not fractures, neither of which was measured. The companion paper from the same cohort found no effect on liver or kidney function and no significant differences in the other outcomes it measured, including quality of life, body composition, physical activity and nutrient intake. Serum delta-tocotrienol did rise, confirming absorption.

3
Tocotrienol Lipid Meta-Analysis (Not Annatto-Specific)

Meta-analysis of 15 randomized controlled trials across 20 arms on tocotrienol supplementation and lipid profile, Complement Ther Med 2020 (PMID 32951713). This replaces an earlier card that referred only to multiple DeltaGold trials with no citation at all.

Pooled participants from 15 randomized trials of tocotrienol supplementation, not annatto DeltaGold specifically.

HDL cholesterol rose 0.146 mmol/L, the only significant lipid change. Total cholesterol (+0.010 mmol/L) and LDL cholesterol (+0.095 mmol/L) were not significant and moved numerically upward. Triglycerides (-0.112 mmol/L) were not significant overall and reached significance only in arms using at least 200 mg/day (-0.177 mmol/L). This analysis did not report inflammatory biomarkers.

Side effects and drug interactions

Common Potential side effects

Generally well tolerated in the one cited trial that assessed safety directly: 430 or 860 mg/day of the annatto extract for 12 weeks did not affect liver or kidney function in the 87 postmenopausal women who completed it. No study cited on this page tested this ingredient for longer than 12 weeks.
Mild GI distress (rare).
Allergic reactions rare.
Theoretical bleeding effects from vitamin E family at very high doses.
Soy sensitivity — verify if allergic (some tocotrienol sources contain trace soy).

Important Drug interactions

Anticoagulants — vitamin E family modest antiplatelet effects.
Statins — additive cholesterol-lowering; complementary mechanism.
Diabetes medications. No trial cited on this page shows a glucose-lowering effect for this ingredient, so any additive effect is theoretical rather than demonstrated. Anyone taking glucose-lowering medication should speak with their prescriber first.
Hormone therapies — DeltaGold may interact; consult.
Pregnancy — limited specific safety data; consult.
Lactation — limited data.
Pre-surgery — discontinue 1-2 weeks for bleeding considerations.

Frequently asked questions about DeltaGold® (Annatto Tocotrienols — American River Nutrition)

What is DeltaGold?

DeltaGold® is the first and only tocopherol-free tocotrienol ingredient from American River Nutrition (Everwell Health subsidiary) — derived from annatto plant (Bixa orellana). Distinguished by ~90% delta + 10% gamma tocotrienol composition with NO interfering tocopherols.

What is DeltaGold used for?

DeltaGold is researched primarily for Cardiovascular, Antioxidant, and Bone Health. This page previously reported a 24-week trial of 250 mg/day in 110 people with type 2 diabetes, with specific figures for fasting glucose, HbA1c, insulin and HOMA-IR.

What is the recommended dosage of DeltaGold?

The clinically studied dose is 430 or 860 mg/day annatto extract (roughly 300 or 600 mg/day tocotrienol) in the 12-week bone marker trial; the quoted 250 mg/day figure comes from a diabetes trial not cited here. Always follow the product label and check with a healthcare provider for personal advice.

Is DeltaGold safe, and does it have side effects?

For most healthy adults, DeltaGold is well tolerated at studied doses. Reported effects can include: Generally well tolerated in the one cited trial that assessed safety directly: 430 or 860 mg/day of the annatto extract for 12 weeks did not affect liver or kidney function in the 87 postmenopausal women who completed it. It may also interact with some medications. DeltaGold 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 DeltaGold interact with any medications?

Possible interactions include: Anticoagulants — vitamin E family modest antiplatelet effects. Statins — additive cholesterol-lowering; complementary mechanism. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for DeltaGold?

NutraSmarts rates the evidence for DeltaGold as Limited (2 out of 5). It is backed by 3 clinical trials and 5 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(5 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. Magosso E, Ansari MA, Gopalan Y, Shuaib IL, Wong JW, Khan NAK, Abu Bakar MR, Ng BH, Yuen KH. Tocotrienols for normalisation of hepatic echogenic response in nonalcoholic fatty liver: a randomised placebo-controlled clinical trial. Nutr J. 2013;12(1):166. doi: 10.1186/1475-2891-12-166.PubMedUsed to support: NAFLD RCT (n=87 hypercholesterolaemic adults with ultrasound-proven NAFLD): mixed tocotrienols 200 mg twice daily for 1 year produced significantly higher normalisation of hepatic echogenic response vs placebo. Note: used a mixed-tocotrienol (palm-type parent) preparation, not annatto/DeltaGold specifically.
  2. Shen CL, Yang S, Tomison MD, Romero AW, Felton CK, Mo H. Tocotrienol supplementation suppressed bone resorption and oxidative stress in postmenopausal osteopenic women: a 12-week randomized double-blinded placebo-controlled trial. Osteoporos Int. 2018;29(4):881-891. doi: 10.1007/s00198-017-4356-x.PubMedUsed to support: Bone RCT using annatto-derived tocotrienol (90% delta-/10% gamma — the DeltaGold composition) in postmenopausal osteopenic women: 12 weeks reduced a bone-resorption marker and oxidative-stress markers vs placebo. Surrogate (biomarker) endpoints, not fracture/BMD; annatto/DeltaGold-specific.
  3. Shen CL, Wang S, Yang S, Tomison MD, Abbasi M, Hao L, Scott S, Khan MS, Romero AW, Felton CK, Mo H. A 12-week evaluation of annatto tocotrienol supplementation for postmenopausal women: safety, quality of life, body composition, physical activity, and nutrient intake. BMC Complement Altern Med. 2018;18(1):198. doi: 10.1186/s12906-018-2263-0.PubMedUsed to support: Brand-specific safety data: explicitly used DeltaGold 70 (annatto seed extract, 90% delta-/10% gamma-tocotrienol). Up to 600 mg/day for 12 weeks did not affect liver or kidney function and caused no treatment-related adverse events. Confirms DeltaGold tolerability and absorption (serum delta-tocotrienol rose). Note that it also found no significant differences between groups in the outcomes it measured, including quality of life, body composition, physical activity and nutrient intake, so it is a safety and absorption study rather than an efficacy result.
  4. Zuo S, Wang G, Han Q, Xiao H, Santos HO, Avelar Rodriguez D, Khani V, Tang J. The effects of tocotrienol supplementation on lipid profile: a meta-analysis of randomized controlled trials. Complement Ther Med. 2020;52:102450. doi: 10.1016/j.ctim.2020.102450.PubMedUsed to support: Meta-analysis (15 RCTs, 20 arms) — honest: significant rise in HDL-C (+0.146 mmol/L) but non-significant effects on total cholesterol and LDL-C overall; triglycerides fell significantly only at doses >=200 mg/day. Tempers strong single-trial cholesterol claims. Tocotrienol parent literature, not annatto-specific.
  5. Qureshi AA, Sami SA, Salser WA, Khan FA. Dose-dependent suppression of serum cholesterol by tocotrienol-rich fraction (TRF25) of rice bran in hypercholesterolemic humans. Atherosclerosis. 2002;161(1):199-207. doi: 10.1016/s0021-9150(01)00619-0.PubMedUsed to support: Classic dose-finding lipid trial (n=90): rice-bran tocotrienol-rich fraction (~100 mg/day) plus AHA Step-1 diet lowered total cholesterol ~20%, LDL ~25% vs baseline via HMG-CoA reductase suppression. Note: rice-bran TRF (parent literature), not annatto/DeltaGold; positive single-source results not fully reproduced in later pooled analyses.