Tocotrienols for Skeletal Muscle Health
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Postmenopausal Syndrome, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 1/10/2019 |
| Start Date: | July 15, 2019 |
| End Date: | December 31, 2022 |
| Contact: | Chwan-Li Shen, PhD |
| Email: | leslie.shen@ttuhsc.edu |
| Phone: | 8067432815 |
Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength
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.
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.
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.
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.
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.
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