NCT06556706已完成不适用
Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amazentis SA
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy
研究概览
简要总结
The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frail (as defined by the Fried frailty criteria)nonsmoking participants in the age group of 65 to 85 years old, both male and female.
- •A body mass index between 18 to 35 kg/m
- •Not on any medications/living with medical conditions that would compromise the study outcome or the safety of the research participant.
- •Able to participate and willing to give written informed consent and to comply with the study restrictions.
- •Willing to be assigned randomly either to the UA or the control group.
排除标准
- •Participants must not have:
- •Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year.
- •A history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
- •A history or presence of allergy to 5-aminolevulinic acid or porphyrins.
- •A history or presence of allergy to lidocaine.
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- •Unwillingness or inability to refrain from consuming alcohol within 48 hours before each visit until the end of said visit.
- •Unwillingness or inability to refrain from consuming 8 or more units of xanthine containing beverages and foods per day during the entire study.
- •Unwillingness to not consume other mitochondrial supplements during the course of the study (such as CoQ10, reseveratrol, NR, NMN etc.) and pomegranate juice
- •unwillingness to not change diet or physical activity levels during the course of the study
- •Unwillingness or inability to undergo a muscle biopsy.
- •Underlying chronic disease, which in the opinion of the investigator, would interfere with study participation or the validity of the measurements.
- •Unintentional weight loss ≤5% of regular body weight during the last 6 months.
- •Medication requirements that may interfere with the interpretation of the results.
- •Loss or donation of blood over 500mL three months prior (male subjects) or four months prior (female subjects) to participating in the study.
- •Smoked (tobacco and/or marijuana mixed with tobacco (THC)) within 6 months prior to the start of the study;
- •Abused drugs, medicine or alcohol within up to 30 days prior to the start of the study (Alcohol: more than 10 drinks a week, with more than 2 drinks a day most days; Drugs: THC, cocaine, opiates, amphetamines/methamphetamines, benzodiazepines, barbiturates, Buprenorphine, Creatin, Methadone metabolite, oxycodone, phencyclidine);
- •A positive COVID-19 test taken 1 week to 24h before study start date.
结局指标
主要结局
Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy
时间窗: 8-weeks
Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy
时间窗: 8-weeks
次要结局
- Changes in knee extension strength measured by a hand dynamometer(8-weeks)
- change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium(8-weeks)
- Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass(8-weeks)
- Changes in grip strength measured by a hand dynamometer(8-weeks)
- mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR(8-weeks)
- Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue(8-weeks)
- change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabilized myofibers(8-weeks)
- Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining)(8-weeks)
- Recording of adverse events(8-weeks)
- Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floor(8-weeks)
- Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling(8-weeks)
- Changes in the timed up and go test (time needed to stand from an armchair, walk a distance of 3 meters, turn around and sit back down in the chair)(8-weeks)
- Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task(8-weeks)
- Changes in distance walked during the six-minute walk test(8-weeks)
- Changes in the 30-second stand test: Participant will stand as many times as s/he can from a seated position for 30-seconds.(8-weeks)
- Changes in Unipedal stance test (UPST): First a ball will be kicked to determine dominant leg, then participant will be asked to stand on one leg (barefoot) with eyes open and again with eyes closed(8-weeks)
研究者
研究点 (2)
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