NCT04874662已完成不适用
Efficacy and Safety of a Mix of Nicotinamide (NAM) and Pyridoxine (vitamin B6) on Muscle Regeneration: a Randomized, Double-blind, Placebo-controlled Study ("Satellite-01 Study").
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年5月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- immunofluorescence measurement
研究概览
简要总结
Assessment of safety and efficacy of NAM/B6 oral administration on the amplification and commitment of satellite cells after a muscle injury
详细描述
NAM/B6 oral administration after a muscle injury ("Satellite-01 study"): Effect on satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) by muscle biopsies, comparing the study intervention (NAM/B6) to the control intervention (placebo)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged ≥18 ≤ 50 years;
- •Subjects must be in good general health, as determined by the investigator or delegate, based on a comprehensive medical evaluation at screening including detailed medical history, full physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests;
- •Body mass index (BMI) between18.5 and 24.9 kg/m2;
- •Normal dietary habits;
- •Willing to adhere to the prohibitions and restrictions specified in the protocol;
- •Must understand the nature of the study and be capable of giving written informed consent and be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.
排除标准
- •Subjects presenting with the following blood pressure (BP) and heart rate (HR) values at the screening visit after 10 minutes in supine position:
- •95 mmHg ≤ systolic blood pressure (SBP) ≤ 140 mmHg,
- •50 mmHg ≤ diastolic blood pressure (DBP) ≤ 95 mmHg,
- •50 bpm < HR < 80 bpm,
- •Or any other out of expected range values considered clinically significant by the investigator;
- •Screening visit 12-lead ECG values which are:
- •120 < PR segment < 220 ms,
- •QRS complex < 120 ms,
- •QTcf < 430 ms,
- •Sign of any trouble of sinusal automatism,
- •Or any other ECG finding considered clinically significant by the investigator;
- •Have any clinically significant abnormalities in serum chemistry, hematology, or urinalysis at screening as judged by the investigator or delegate;
- •Active smokers;
- •Vegetarians or vegans;
- •Performed structured exercises within 3 months prior to participation in the study;
- •History or current use of anabolic steroids and/or growth hormone;
- •Use of corticosteroids within 3 months prior to participation in the study;
- •Current use of anticoagulant or anti-aggreging agents;
- •History or current use since 2 weeks before inclusion of any of the prohibited medications as detailed in Section 6.6.2;
- •History or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, musculoskeletal, psychiatric, systemic or infectious disease;
- •History or current use of drugs or alcohol (alcohol consumption > 40 grams/day);
- •Known intolerance to foods containing the ingredients under investigation;
- •Knee pain that prevents application of the electrical muscle stimulation protocol;
- •Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- •Subjects under administrative or legal supervision;
- •Have participated in a clinical study in the last 3 months and received compensation beyond a certain approved and predefined limit.
结局指标
主要结局
immunofluorescence measurement
时间窗: 9 days
Number of satellite cells as measured by immunofluorescence (Pax7 and myogenin antibodies to detect amplifying and committed satellite cells, respectively) on sections of muscle biopsies from the stimulated leg (leg 2) at day 4 and day 8 (muscle biopsies: MB3 and MB5), comparing the study intervention (NAM/B6) to the control intervention (placebo)
次要结局
未报告次要终点
研究者
研究点 (1)
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