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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a type of vitamin E, called tocotrienols, can reduce the negative effects of obesity in postmenopausal women. Researchers aim to determine if taking tocotrienol supplements for 24 weeks improves health outcomes like weight management and inflammation. Participants will be divided into two groups: one will receive the tocotrienol supplement (DeltaGold® Tocotrienol 70%), and the other will receive a placebo (a non-active substance). Women who are postmenopausal, have a BMI of 30 or higher, and lead a sedentary lifestyle may be suitable for this trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that delta-tocotrienol, a type of vitamin E, is generally safe for people. Studies have found no major side effects in healthy individuals who took it. For instance, one study found that taking up to 600 mg of tocotrienol from annatto daily for 12 weeks was safe for postmenopausal women, who did not experience any liver or kidney problems. This suggests that tocotrienol is well-tolerated. However, consulting a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard obesity treatments that often involve lifestyle changes or medications targeting appetite or fat absorption, DeltaGold® Tocotrienol 70% offers a unique approach. This treatment uses tocotrienols, a form of vitamin E, that may influence fat metabolism differently. Researchers are particularly excited because tocotrienols have shown promise in reducing inflammation and oxidative stress, which are key factors in obesity. Plus, being derived from natural sources might offer a gentler alternative with fewer side effects compared to traditional drugs.

What evidence suggests that tocotrienols might be an effective treatment for obesity?

Research has shown that tocotrienols, a form of vitamin E, might help with obesity-related issues in postmenopausal women. In animal studies, tocotrienols lowered blood fats and inflammatory substances. A study with postmenopausal women found that taking tocotrienols for 12 weeks was safe and well-tolerated. Tocotrienols also improved levels of beneficial nutrients in the blood while reducing less beneficial ones. These findings suggest that tocotrienols could address the negative effects of obesity, such as inflammation and nutrient imbalances. Participants in this trial will receive either a tocotrienol softgel or a placebo softgel to further evaluate these potential benefits. ^{1 3 4 5 6}

Who Is on the Research Team?

Chwan-Li Shen, PhD

Principal Investigator

Texas Tech University Health Sciences Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7064069/

Actions of annatto-extracted tocotrienol supplementation ... In our previous animal study, we have shown that TT supplementation to diet reduced serum triglycerides and proinflammatory adipokines in obese ...

2. ctv.veeva.com ctv.veeva.com/study/tocotrienols-for-obesity-of-postmenopausal-women

Tocotrienols for Obesity of Postmenopausal Women The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women.

3. withpower.com withpower.com/trial/phase-2-obesity-2-2019-1027f

Tocotrienols for Obesity · Info for Participants ... DeltaGold® Tocotrienol 70% will have tolerable side effects & efficacy for patients with Obesity, Obesity and Postmenopausal. Learn more about the study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6022510/

A 12-week evaluation of annatto tocotrienol supplementation ... Annatto-derived tocotrienol up to 600 mg per day for 12 weeks appeared to be safe in postmenopausal osteopenic women, particularly in terms of liver and kidney ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2021.766711/full

Tocotrienol Supplementation Led to Higher Serum Levels ... The results confirmed higher serum levels of tocotrienols and lysophospholipids, but lower acylcarnitines and catabolites of tryptophan and steroids in subjects ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03705845

Tocotrienols for Obesity of Postmenopausal Women The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators ...