Effectiveness of ResArgin on Adult's Body Composition and Health: a Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Body composition change from baseline in fat mass and fat free mass as assessed by a DEXA scan at 90 days
研究概览
简要总结
The goal of this clinical trial is to learn if the supplement ResArgin (a reservatrol-based supplement) works to slow down muscle loss during a period of fat loss. Other related health outcomes such as sleep, mood, and activity will be assessed. The main questions it aims to answer are:
Does ResArgin improve muscle loss? Does ResArgin improve sleep quality, activity, mood, and body satisfaction.
Researchers will compare ResArgin to a placebo (a look-alike substance that contains no active ingredients) to see if ResArgin works to improve muscle loss and related health outcomes.
Participants will:
Take ResArgin or the Placebo every day for 3 months
Assessment will occur at Baseline, Day 30, Day 60, and Day 90.
Participants will complete a daily diary of their mood and health.
详细描述
Study Purpose: Examine the effectiveness of ResArgin in attenuating muscle loss during a period of fat loss in overweight and mildly obese men and women.
Outcomes: Primary outcomes will be body composition. Secondary outcomes will be physical activity, food cravings, health-related quality of life, body satisfaction, basal metabolic rate, sleep behaviors, mood, anxiety, and perceived stress.
Study Design • Randomized double-blind placebo-controlled trial
o N = 60 men and women (30 adults in the ResArgin Condition and 30 adults in the Placebo Condition).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight and mildly obese adults
- •age range between 25 to 60 years
排除标准
- •metabolic or endocrine related dysregulation including but not limited to: diagnosis of type I or type II diabetes, liver, kidney, or pancreatic dysfunction.
- •history of seizures or epilepsy-related disorders
- •musculoskeletal issues that would prohibit them from engaging in spontaneous activity,
- •metabolic disorder
- •sleep disorder
- •psychiatric condition
- •dietary aversions or restrictions including any animal sources of protein, dairy, fruits/vegetables, nut/seed allergy, eggs, and wheat/gluten or are currently following a carbohydrate restricted (under 20%) habitual diet.
- •consume excessive amounts of alcohol (>3 drinks/d)
- •actively intermittent fasting
- •actively trying to lose weight or have lost more than ± 3kg in previous 3 months
- •trying to conceive
- •changed their birth control in the past 3 months.
研究组 & 干预措施
ResArgin
A resveratrol-based supplement. Participants will receive a daily oral dose of ResArgin containing [50 mg/d] of trans-Resveratrol for 90 days.
干预措施: ResArgin (Dietary Supplement)
placebo
Placebo consists of oat hull. Participants receive a daily oral dose of a placebo matching the appearance and dosage form of ResArgin for 90 days.
干预措施: ResArgin (Dietary Supplement)
结局指标
主要结局
Body composition change from baseline in fat mass and fat free mass as assessed by a DEXA scan at 90 days
时间窗: From enrollment to the end of intervention at 90 days
This will be assessed objectively by a trained health professional.
次要结局
- Change from baseline in health-related quality of life, sleep quality, activity, and mood at 90 days(Change from Baseline to Day 90)
研究者
Dr. Heather Hausenblaus
Professor
Jacksonville University