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Tocotrienols for Skeletal Muscle Health (VitE-muscle)

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ClinicalTrials.gov Identifier: NCT03708354
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief 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.

Condition or disease Intervention/treatment Phase
Dynapenia Postmenopausal Women Drug: placebo softgel Drug: DeltaGold® Tocotrienol 70% Phase 1 Phase 2

Detailed Description:
Sarcopenia is a major health issue in postmenopausal women (PMW). The long-term goal is to develop a new strategy featuring a dietary supplement for alleviating sarcopenia in postmenopausal women. The objective is to test a dietary supplement intervention (delta-tocotrienols, TT) for feasibility, and to quantitatively assess its effects on postmenopausal women with sarcopenia. Due to the limited budget, the investigators will not assess appendicular muscle mass in this pilot study and will focus on muscle strength and function. The central hypotheses are that (i) TT supplementation will alleviate age-associated skeletal muscular dysfunction of postmenopausal women with low muscle strength, and (ii) such changes in skeletal muscle are associated with lowered oxidative stress and inflammation wherein the targets are oxylipins (OxL) and endocannabinoids (eCB), and possible modification of gut microbiota. This is a randomized double-blinded placebo-controlled trial. Fifty-two qualified subjects will be assigned to placebo or TT for 24 weeks. There are 4 specific aims (SA) in this study. SA 1 is to evaluate the effects of TT intervention on endurance, strength, function and size of the lower-extremity musculature in PMW with low muscle strength. SA 2 is to measure the effects of TT intervention on oxidative stress and inflammatory levels. SA 3 is to measure the effects of TT intervention on inflammatory OxL and eCB levels in plasma and muscle tissue. SA 4 is to evaluate the effects of TT intervention on abundance and composition of intestinal bacterial in feces. The outcome measures of SA 1 will be assessed at the baseline, after 12 and 24 weeks. The outcome measures of SA 2, SA 3, and SA 4 will be assessed at the baseline and after 24 weeks. In addition, at 0 and 24 weeks, the investigators will monitor (i) compliance by pill count and (ii) changes in lifestyle throughout the study via food intake surveys and physical activity surveys. Descriptive statistics, bivariate tests, and general/generalized linear mixed modeling will be used for the quantitative analysis on the effects of the TT intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: dietary supplement
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Placebo softgels will be of the same size/color as the active softgels.
Primary Purpose: Prevention
Official Title: Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arm Intervention/treatment
Placebo Comparator: Control
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.
Drug: placebo softgel
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.
Other Name: olive oil

Active Comparator: 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.
Drug: DeltaGold® Tocotrienol 70%
Each TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% δ-TT+10% γ-TT) with a 70% purity, representing 300 mg TT.
Other Name: tocotrienol




Primary Outcome Measures :
  1. lower-body muscle endurance [ Time Frame: 24 weeks ]
    assessed by 6-min walk test


Secondary Outcome Measures :
  1. 8-OHdG [ Time Frame: 24 weeks ]
    urine 8-hydroxy-2'-deoxyguanosine

  2. oxylipins [ Time Frame: 24 weeks ]
    oxylipins levels in plamsa and skeletal muscle biopsy

  3. gut microbiome [ Time Frame: 24 weeks ]
    abundance and composition of intestine microbiome in feces

  4. handgrip strength [ Time Frame: 24 weels ]
    assessed by a hand dynamometer

  5. lower-body muscle strength [ Time Frame: 24 weeks ]
    assessed by isometric knee extension muscle strength

  6. functional performance [ Time Frame: 24 weeks ]
    assessed by Time Up and Go test

  7. Muscle size of the lower-extremity musculature [ Time Frame: 24 weeks ]
    cross-sectional area of the rectus femoris assessed using a diagnostic ultrasound device

  8. F2-isoprostanes [ Time Frame: 24 weeks ]
    F2-isoprostanes in urine

  9. TNF-alpha [ Time Frame: 24 weeks ]
    Transforming necrosis factor-alpha in urine

  10. hs-CRP [ Time Frame: 24 weeks ]
    high sensitivity C-reactive protein

  11. endocannabinoid [ Time Frame: 24 weeks ]
    endocannabinoid levels in plasma and muscle biopsy



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Aging and decline of estrogen are factors that contribute to skeletal muscle disorders in postmenopausal women.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Postmenopausal women (60-85 yr) not on hormone replacement therapy in the past year.
  2. Normal liver, kidney, thyroid function (TSH), serum 25-OH vitamin D (≥ 20 ng/ml)-sent to Quest Diagnostic Laboratory.
  3. Grip strength weakness (<20 kg).
  4. Sedentary -evaluated by using self-administered International Physical Activity Questionnaire (IPAQ) short form.

Exclusion criteria:

  1. Serious chronic disease (e.g., unstable CVD, uncontrolled diabetes, uncontrolled hypertension, active cancer, Parkinson's disease).
  2. Taking hormone replacement therapy within 3 months before study starts.
  3. Taking medications (i.e., steroids) within 3 months before study starts, since steroids could affect muscle function.
  4. Taking supplements (i.e., fish oil) that have anti-inflammatory action during the past 3 months.
  5. Having dementia or other medical/eating disorder (i.e. currently receiving an appetite stimulant).
  6. Self-report of >10% body weight loss in the past month.
  7. Taking anticoagulants that may interact with tocotrienols.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708354


Contacts
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Contact: Chwan-Li Shen, PhD 8067432815 leslie.shen@ttuhsc.edu

Locations
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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Chwan-Li Shen, PhD Texas Tech University Health Sciences Center

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT03708354     History of Changes
Other Study ID Numbers: L19-011
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Texas Tech University Health Sciences Center:
skeletal muscle strength

Additional relevant MeSH terms:
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Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances