A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of AMAZ-02 on Muscle Function in Otherwise Healthy Middle-aged, Overweight and Inactive Individuals

Amazentis SA1 个研究点分布在 1 个国家目标入组 90 人2018年3月6日

适应症Muscle Function, Mitochondrial Function Overweight Healthy Aging

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Muscle Function, Mitochondrial Function
发起方: Amazentis SA
入组人数: 90
试验地点: 1
主要终点: Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This is a Phase 2 randomized, double-blind, placebo-controlled study enrolling 90 healthy, overweight, middle aged subjects (30 placebo, 30 low dose and 30 high dose AMAZ-02 intervention), 40-65 years of age, who are otherwise healthy. AMAZ-02, a food derived ingredient, will be given as a daily oral dose for 4 months.

注册库

clinicaltrials.gov

开始日期

2018年3月6日

结束日期

2019年9月30日

最后更新

3年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Amazentis SA

责任方

Sponsor

入排标准

入选标准

•Healthy males and females 40 to 65 years of age, inclusive
•Subjects who have not participated within the last 1 year in clinical trials focused on improving muscle function and physical performance
•Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) or,
•Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
•Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
•Double-barrier method
•Intrauterine devices
•Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
•Vasectomy of partner (shown successful as per appropriate follow-up)
•Body mass index (BMI) between 25.0 and 34.9 kg/m2, inclusive

排除标准

•Women who are pregnant, breast feeding, or planning to become pregnant during the trial
•Smokers or ex-smokers within the past 1 year from screening, including use of vaporizers or e-cigarettes
•Participation in another clinical study or receipt of an investigational drug within 60 days of the screening visit
•Blood donation within 1 month of baseline, as well as planned donation 1 month after end of study.
•Recent history (within the last 2 years) of alcohol or other substance abuse
•Use of medicinal marijuana.
•Unable to swallow capsules
•Regular participation in a structured exercise program with physical activity levels in Category 2 or higher defined as 20 min vigorous activity 3-times per week, moderate activity for 30 min 5 days per week or more
•Inability to abstain from intensive muscular effort
•Individuals who have engaged in 1 hour or more per week of resistance training in the past 3 months.

结局指标

主要结局

Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo

时间窗: 4 months

次要结局

Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 60 between AMAZ-02 groups and placebo(2 months)
Change in exercise tolerance as assessed by time to fatigue on the cycle ergometer from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo(2, 4 months)
Change in distance walked in the 6-minute walk test as a measure of aerobic endurance from baseline to day 120 between AMAZ-02 groups and placebo(4 months)
Change in 3-day food records reviewed at baseline and days 60 and 120(2, 4 months)
Change in in vivo mitochondrial gene expression from baseline to day 120 between AMAZ-02 groups and placebo as assessed via microarray performed on muscle biopsy(4 months)
Change in physical performance on the cycle ergometry defined as the time to reach 85% of maximum heart rate from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo(2, 4 months)
Change in lean body mass as assessed by dual X-ray absorptiometry (DXA) from baseline to day 120 between AMAZ-02 groups and placebo(4 months)
Change in handgrip strength of the non-dominant hand as assessed by Jamar dynamometry from baseline to day 120 between AMAZ-02 groups and placebo(4 months)
Change in the 30-second chair stand test from baseline to day 120 between AMAZ-02 groups and placebo(4 months)
Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's quality of life as assessed by the 36-item short form (SF-36) questionnaire(4 months)
Change from baseline to day 60 and from baseline to day 120 in serum lipid profile, insulin, and HbA1C between AMAZ-02 groups and placebo(2, 4 months)
Change in plasma muscle function biomarkers (myostatin, follistatin, inflammatory cytokines and mitokines) from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo(2, 4 months)
Change in the gut microbial diversity at baseline and at day 120 between AMAZ-02 groups and placebo assessed via 16s RNA sequencing performed on fecal samples(4 months)
Change in isokinetic lower body muscle strength as assessed by the Biodex isokinetic dynamometer from baseline to day 120 between AMAZ-02 groups and placebo(4 months)
Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's perceived exertion during exercise testing as assessed by the Borg Rating of Perceived Exertion Scale (Scale from 6-20)(2, 4 months)
Change from baseline to days 60 and 120 between AMAZ-02 groups and placebo in participant' resting energy expenditure in Kcal/ day via the Cardiocoach CO2 system(2, 4 months)
Change in acylcarnitine profile in plasma via Metabolomics assessments from baseline to day 60, and from baseline to day 120 between AMAZ-02 groups and placebo(2, 4 months)
The change in the international physical activity questionnaire score (IPAQ) from baseline to day 120 between AMAZ-02 500mg/d and 1000mg/d and placebo.(4 months)
Change in gait speed from baseline to day 120 between AMAZ-02 groups and placebo as derived from the 6-minute walk test(4 months)