Tocotrienols for Skeletal Muscle Health
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 12/31/2019 |
| Pirmasis pateikimas: | 10/09/2018 |
| Numatytas registravimas pateiktas: | 10/11/2018 |
| Pirmas paskelbtas: | 10/16/2018 |
| Paskutinis atnaujinimas pateiktas: | 01/14/2020 |
| Paskutinis atnaujinimas paskelbtas: | 01/17/2020 |
| Faktinė studijų pradžios data: | 04/14/2019 |
| Numatoma pirminio užbaigimo data: | 12/30/2022 |
| Numatoma studijų užbaigimo data: | 12/30/2022 |
Būklė ar liga
Intervencija / gydymas
Drug: Control
Drug: Intervention
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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: 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. |
| 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: Intervention Each TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% δ-TT+10% γ-TT) with a 70% purity, representing 300 mg TT. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 60 Years Į 60 Years |
| Tinkamos studijoms lytys | Female |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. lower-body muscle endurance [24 weeks]
Antrinės rezultatų priemonės
1. 8-OHdG [24 weeks]
2. oxylipins [24 weeks]
3. gut microbiome [24 weeks]
4. handgrip strength [24 weels]
5. lower-body muscle strength [24 weeks]
6. functional performance [24 weeks]
7. Muscle size of the lower-extremity musculature [24 weeks]
8. F2-isoprostanes [24 weeks]
9. TNF-alpha [24 weeks]
10. hs-CRP [24 weeks]
11. endocannabinoid [24 weeks]
