Tocotrienols for Skeletal Muscle Health

Postmenopausal Women Clinical Trial

— VitE-muscle  

Official title:

Tocotrienols Supplementation for Postmenopausal Women With Low Muscle Strength

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03708354
• Other study ID #: L19-011
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 15, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dynapenia
• Postmenopausal Women

Intervention

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.
• DeltaGold® Tocotrienol 70%
Each TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% d-TT+10% ?-TT) with a 70% purity, representing 300 mg TT.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lower-body muscle endurance	assessed by 6-min walk test	24 weeks
Secondary	8-OHdG	urine 8-hydroxy-2'-deoxyguanosine	24 weeks
Secondary	oxylipins	oxylipins levels in plamsa and skeletal muscle biopsy	24 weeks
Secondary	gut microbiome	abundance and composition of intestine microbiome in feces	24 weeks
Secondary	handgrip strength	assessed by a hand dynamometer	24 weels
Secondary	lower-body muscle strength	assessed by isometric knee extension muscle strength	24 weeks
Secondary	functional performance	assessed by Time Up and Go test	24 weeks
Secondary	Muscle size of the lower-extremity musculature	cross-sectional area of the rectus femoris assessed using a diagnostic ultrasound device	24 weeks
Secondary	F2-isoprostanes	F2-isoprostanes in urine	24 weeks
Secondary	TNF-alpha	Transforming necrosis factor-alpha in urine	24 weeks
Secondary	hs-CRP	high sensitivity C-reactive protein	24 weeks
Secondary	endocannabinoid	endocannabinoid levels in plasma and muscle biopsy	24 weeks