What side effects are associated with this type of intervention?

Common treatments for obesity with antioxidant properties, such as tocotrienols and omega-3 fatty acids, generally have a good safety profile. Tocotrienols are noted for their potential benefits in reducing inflammation without significant adverse effects reported. Omega-3 fatty acids, while beneficial, may cause mild side effects such as gastrointestinal discomfort, including nausea and diarrhea. Vitamin E, another antioxidant, is generally well-tolerated but can cause headaches, diarrhea, and fatigue at high doses. Overall, these treatments are considered safe with modest side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, and liraglutide. These treatments primarily focus on appetite suppression, fat absorption inhibition, and metabolic rate enhancement. While tocotrienols, a form of vitamin E with potent antioxidant properties, are being studied for their potential to mitigate obesity-induced chronic low-grade inflammation, there are no current FDA-approved obesity treatments specifically targeting antioxidant pathways. However, the exploration of tocotrienols could represent a novel approach in the management of obesity-related inflammation.

What other types of research exist?

Promising alternatives to tocotrienols for mitigating obesity-induced chronic low-grade inflammation include: 1) Omega-3 fatty acids, which have shown neuroprotective benefits and may reduce inflammation. 2) Vitamin E (alpha-tocopherol), which has antioxidant properties and has been studied for various health benefits. 3) Diets high in fiber, beta-carotene, folate, and vitamins C and B6, which have been associated with protective effects against various conditions. 4) NSAIDs like aspirin, which have shown potential in reducing inflammation and cancer risk, though their use should be carefully considered due to potential side effects.

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Vitamin E Supplement

Tocotrienols for Obesity (VitE-obesity Trial)

Phase 1 & 2

Waitlist Available

Led By Chwan-Li Shen, PhD

Research Sponsored by Texas Tech University Health Sciences Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, as tocotrienols are a type of vitamin E and an antioxidant, potential side effects could include stomach discomfort, fatigue, headache, rash or bruising more easily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fat mass

visceral adipose tissue

Secondary study objectives

FASN

Gut microbiota

HDL

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: InterventionActive Control1 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: ControlPlacebo Group1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity often target metabolic pathways and inflammation. Antioxidants like tocotrienols, a form of vitamin E, are studied for their potential to mitigate obesity-induced chronic low-grade inflammation by reducing oxidative stress. This is important for obesity patients as chronic inflammation is linked to various metabolic disorders, including insulin resistance and cardiovascular diseases. Other treatments include lifestyle interventions such as diet and exercise, which aim to create a caloric deficit and improve metabolic health. Pharmacological treatments may include appetite suppressants and medications that alter fat absorption or metabolism. These treatments collectively help in reducing body weight, improving metabolic parameters, and decreasing the risk of obesity-related complications.

Effects of tocotrienols supplementation on markers of inflammation and oxidative stress: A systematic review and meta-analysis of randomized controlled trials.Neuroprotective and Anti-Obesity Effects of Tocotrienols.Effects of tocotrienols on life span and protein carbonylation in Caenorhabditis elegans.