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Vitamin E

Intervention for Muscle Weakness (VitE-muscle 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

Sarcopenia, defined as a reduction in muscle mass and strength, is a major health concern for postmenopausal women. Evidence suggests that lowering inflammation levels is an important strategy to help mitigate age-related muscle dysfunction and loss. In this pilot study, the investigators will study a tocotrienol (vitamin-E isomer) intervention for feasibility and quantify its effects on postmenopausal women with low muscle strength. A double blind, placebo controlled trial will be conducted on fifty-two qualified subjects. The participants will be assigned to placebo or tocotrienols for 24 weeks. All participants will receive an Omron Alvita Optimized Pedometer. The investigators will measure muscular endurance, strength, and size and gut microbiome profiles at 0, 12, and 24 weeks. In addition, the investigators will measure serum and muscle inflammatory levels at 0 and 24 weeks. All data will be analyzed statistically at p\<0.05.

Eligible Conditions
  • Muscle Weakness
  • Postmenopausal

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
lower-body muscle endurance
Secondary outcome measures
8-OHdG
F2-isoprostanes
Muscle size of the lower-extremity musculature
+8 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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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor
104 Previous Clinical Trials
10,939 Total Patients Enrolled
Chwan-Li Shen, PhDPrincipal InvestigatorTexas Tech University Health Sciences Center
1 Previous Clinical Trials
60 Total Patients Enrolled
~0 spots leftby Sep 2025