Tocotrienols for Obesity

(VitE-obesity Trial)

Overseen By Chwan-Li Shen, PhD

Age: Any Age

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Texas Tech University Health Sciences Center

Must not be taking: Anticoagulants, Steroids, Statins

Disqualifiers: Unstable weight, Cardiovascular, Diabetes, Hypertension, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but if you change any medications or supplements that affect lipid metabolism after the study starts, you will have to leave the trial. Also, you cannot participate if you are taking anticoagulants that may interact with tocotrienols.

Is tocotrienol safe for human use?

Studies have shown that delta-tocotrienol is generally safe in humans, with no significant side effects reported in healthy subjects after single and multiple doses. Additionally, research on tocotrienol in rats over 13 weeks showed no adverse effects, suggesting a good safety profile. ^{1 2 3 4 5}

How is the treatment DeltaGold® Tocotrienol 70% unique for obesity?

DeltaGold® Tocotrienol 70% is unique because it focuses on tocotrienols, a form of vitamin E, which may have different effects on fat metabolism compared to other treatments like vitamin D or functional foods. This treatment could offer a novel approach by potentially targeting specific mechanisms in fat regulation and inflammation. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial aims to see if taking tocotrienols (a type of vitamin E) for several months can help reduce obesity-related health issues in postmenopausal women by lowering inflammation. Tocotrienols are a subclass of vitamin E known for their anti-inflammatory and antioxidant properties, and have been studied for their potential to reduce obesity-related complications.

Research Team

Chwan-Li Shen, PhD

Principal Investigator

Texas Tech University Health Sciences Center

Eligibility Criteria

This trial is for postmenopausal women with obesity (BMI ≥30 kg/m2) who are generally inactive. They must have stable body weight and not be taking medications or supplements that affect lipid metabolism. Women with serious chronic diseases or those on anticoagulants that may interact with tocotrienols cannot participate.

Inclusion Criteria

PMW with BMI ≥30 kg/m2.

Sedentary using International Physical Activity Questionnaire (IPAQ-short form)

You have a sedentary lifestyle, as determined by the International Physical Activity Questionnaire (IPAQ-short form).

Exclusion Criteria

Unstable body weight (more than 5% change in body weight) within 3 months before intervention begins

Changes to medications or supplements (i.e., steroids, statins) within 3 months of the baseline study visit that could affect lipid metabolism

If they change any medications/supplements after the baseline visit that will affect lipid metabolism, their study participation will end

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tocotrienol or placebo softgel daily for 24 weeks

24 weeks

3 visits (in-person) at baseline, 12 weeks, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DeltaGold® Tocotrienol 70%
• placebo softgel

Trial Overview The study tests if a form of vitamin E called DeltaGold® Tocotrienol can help reduce the negative effects of obesity in postmenopausal women over 24 weeks, compared to a placebo. Participants will be randomly assigned to either the tocotrienol group or a placebo group.

Participant Groups

Group I: Intervention Active Control 1 Intervention

One 430 mg tocotrienol softgel daily for 24 weeks. Each tocotrienol softgel (DeltaGold® Tocotrienol 70%) contains 430 mg tocotrienol (90% δ-tocotrienol+10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.

Group II: Control Placebo Group 1 Intervention

One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels.

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and safety of vitamin E δ-tocotrienol after single and multiple doses in healthy subjects with measurement of vitamin E metabolites. [2019]

2. Turkey pubmed.ncbi.nlm.nih.gov

Effects of Delta-tocotrienol Supplementation on Liver Enzymes, Inflammation, Oxidative stress and Hepatic Steatosis in Patients with Nonalcoholic Fatty Liver Disease. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Emulsions as delivery systems for gamma and delta tocotrienols: Formation, properties and simulated gastrointestinal fate. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacokinetics, and Bioavailability of Higher Doses of Tocotrienols in Healthy Fed Humans. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Physiological effects and tissue distribution from large doses of tocotrienol in rats. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Effect of Carnitine and herbal mixture extract on obesity induced by high fat diet in rats. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of vitamin D supplementation on body fat accumulation, inflammation, and metabolic risk factors in obese adults with low vitamin D levels - results from a randomized trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation decreases visceral adiposity and normalizes leptinemia and circulating TNF-α levels in western diet-fed obese rats. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Food ingredients as anti-obesity agents: a review. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Enhanced anti-obesity activities of red mold dioscorea when fermented using deep ocean water as the culture water. [2021]