A Phase 1/2 interventional study of placebo softgel and DeltaGold® Tocotrienol 70% in Dynapenia and Postmenopausal Women, sponsored by Texas Tech University Health Sciences Center. Withdrawn at 1 site in United States. Open to female participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by Texas Tech University Health Sciences Center · Phase 1/2, Interventional, and Prevention
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.
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.
Texas Tech University Health Sciences Center is the lead sponsor of 100 studies on the registry; 14 are open to participants now.
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Exclusion criteria:
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 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%
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.
Also known as: olive oil
Each TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% δ-TT+10% γ-TT) with a 70% purity, representing 300 mg TT.
Also known as: tocotrienol
lower-body muscle endurance
assessed by 6-min walk test
Time frame: 24 weeks
8-OHdG
urine 8-hydroxy-2'-deoxyguanosine
Time frame: 24 weeks
oxylipins
oxylipins levels in plamsa and skeletal muscle biopsy
Time frame: 24 weeks
gut microbiome
abundance and composition of intestine microbiome in feces
Time frame: 24 weeks
handgrip strength
assessed by a hand dynamometer
Time frame: 24 weels
lower-body muscle strength
assessed by isometric knee extension muscle strength
Time frame: 24 weeks
functional performance
assessed by Time Up and Go test
Time frame: 24 weeks
Muscle size of the lower-extremity musculature
cross-sectional area of the rectus femoris assessed using a diagnostic ultrasound device
Time frame: 24 weeks
F2-isoprostanes
F2-isoprostanes in urine
Time frame: 24 weeks
TNF-alpha
Transforming necrosis factor-alpha in urine
Time frame: 24 weeks
hs-CRP
high sensitivity C-reactive protein
Time frame: 24 weeks
endocannabinoid
endocannabinoid levels in plasma and muscle biopsy
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2019 (actual). Primary completion is estimated for Dec 2022, 44 months after the start.
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This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tocotrienols
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