NCT07428889已完成不适用
A Randomized, Controlled, Pilot Trial to Assess the Effects of a Proprietary Nutritional Supplement on Nicotinamide Adenine Dinucleotide (NAD+) Responses in Healthy Adults
Shaklee Corporation2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2026年2月17日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Nicotinamide adenine dinucleotide response in whole blood
研究概览
简要总结
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.
详细描述
The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+), its metabolites, and markers of health in response to a proprietary nutritional supplement in generally healthy adults, compared to 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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, ≥45 to ≤65 years of age
- •BMI ≥18.5 and <30.0 kg/m2
- •Ambulatory and currently free of injury or other physical impairment that hinders mobility.
- •Willing to use personal smart phone with operating system (Android version 12.0 or newer; iOS version 16 or newer).
- •Willingness to maintain current skin care regimen and avoid any skin-related medical procedures.
- •Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
排除标准
- •Is currently following, or planning to be on, a weight loss regimen.
- •Weight loss or gain >4.5 kg.
- •History of gastrointestinal surgery for weight reducing purposes.
- •History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
- •History of neurologic disorder that could produce cognitive deterioration.
- •History of bouts of delirium, confusion, repeated minor head injury or a single injury.
- •History of unconventional sleep patterns or a diagnosed sleep disorder.
- •History of any infective or inflammatory brain disease.
- •Use of tobacco/nicotine products.
- •Use of hemp/marijuana products.
- •Unstable use of any prescription medication.
- •Unstable use (initiation or change in dose) of hormonal contraceptives or therapy.
- •Use of any dietary supplements (orally or infused), other than a conventional once daily multi-vitamin.
- •Use of medication(s) or dietary supplement(s) known to affect absorption.
- •Recent history of or strong potential for alcohol or substance abuse.
- •Exposed to any non-registered drug product.
- •A score of <7 on the Vein Access Scale Assessment.
- •History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders.
- •Uncontrolled hypertension.
- •Known allergy to any ingredients contained in the study product.
- •Any signs or symptoms of active infection of clinical relevance.
- •History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- •History of any major trauma or major surgical event.
- •Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use of sex hormones for contraception.
- •An employee or representative who has a financial interest in Sponsor organization.
研究组 & 干预措施
Proprietary nutritional supplement
Experimental
Participants will take the experimental supplement orally, daily.
干预措施: Proprietary Nutritional Supplement (Dietary Supplement)
Placebo supplement
Placebo Comparator
Participants will take the placebo supplement orally, daily.
干预措施: Placebo Supplement (Dietary Supplement)
结局指标
主要结局
Nicotinamide adenine dinucleotide response in whole blood
时间窗: Baseline to Day 14
次要结局
- Nicotinamide adenine dinucleotide metabolite responses(Baseline to Days 1, 7, 14, and 30)
- Subjective cognitive function visual analog scales(Baseline to Days 30 and 60)
- Subjective quality of life questionnaire(Baseline to Days 30 and 60)
- Metabolic health markers(Baseline to Days 30 and 60)
- Biological age(Baseline to Days 30 and 60)
- Cardiorespiratory fitness(Baseline to Day 30 and 60)
- Physical function(Baseline to Days 30 and 60)
- Subjective skin assessment questionnaire(Days 30 and 60)
研究者
研究点 (2)
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