Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight but otherwise healthy adults.
详细描述
Hypothesis
The investigator's hypothesize that daily intake for a 3-month period of the ISOThrive supplement vs. a placebo will demonstrate beneficial effects on the primary outcome measure of body weight and secondary outcome measures (hunger/satiety, health-related measures and self-reported quality of life) in a group of overweight adults.
Specific Aims
- To determine the effects of the ISOThrive supplement on body weight in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate a clinically meaningful reduction in body weight in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To determine the effects of the ISOThrive supplement on hunger/satiety, body composition, waist circumference, blood pressure, blood glucose levels, blood lipid levels, inflammatory and satiety serum markers and self-reported quality of life in overweight adults encouraged to reduce calories and exercise regularly, but on an unrestricted diet and without specific exercise instruction. Specifically, to demonstrate an improvement in hunger/satiety and a clinically meaningful improvement in other measures in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To demonstrate the safety of the ISOThrive supplement in terms of its impact on blood, liver and kidney function in overweight adults. Specifically, to demonstrate the lack of a negative impact on blood, liver and kidney function tests in a group of overweight adults after 3 months of daily consumption of the ISOThrive supplement.
- To determine the effects of the ISOThrive supplement on Gut health. Specifically, to demonstrate improvement in Gut health as measured by abdominal bloating, abdominal gas, and abdominal pain/discomfort at the end of 3 months of daily consumption of the ISOThrive supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of 25 and over and weight not > 350lb
- •Age between 18 and 75
- •Non-smokers
- •Able to read and write in English
排除标准
- •Pregnant and/or lactating women
- •Evidence or history of substance or alcohol abuse (include if over 5years)
- •History of major depression, bipolar disorder or schizophrenia, any type of obsessive-compulsive disorder
- •Current history of migraine headaches (include if controlled with medication)
- •Current use of any prescription or non-prescription weight loss products
- •Tobacco use
- •Active eating disorder including anorexia nervosa and bulimia
- •Known sensitivity or allergy to any of the ingredients in the product
- •Symptomatic coronary artery disease or congestive heart failure
- •History of a stroke in the past year
- •Symptomatic arrhythmia
- •Uncontrolled hypertension (i.e. systolic pressure >180 mmHg and or diastolic > 110 mmHg)
- •History of a seizure in the past 5 years
- •Any cancer in the past 5 years other than non-melanoma skin cancer or in-situ cervical cancer
- •Active or history of inflammatory bowel disease
- •Current use of TNF-alpha inhibitor medications
- •Current use of COX-2 inhibitor medications
- •Current use of JAK inhibitor medications
- •History of weight loss procedures including bariatric surgery
研究组 & 干预措施
ISOThrive supplement 1
Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period.
干预措施: ISOThrive Supplement (Dietary Supplement)
ISOThrive supplement 2
Participants assigned to the ISOThrive supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period.
干预措施: ISOThrive Supplement (Dietary Supplement)
Placebo supplement
Participants assigned to the placebo supplement arm will be provided with daily servings of a supplement for 3 months. Participants will be instructed to take the supplement with water daily, once/day in the morning during the treatment period.
干预措施: Placebo Supplement (Dietary Supplement)
结局指标
主要结局
Body Weight
时间窗: Up to 12 weeks
Body weight will be measured at the beginning and at the end of the study using a calibrated digital scale.
次要结局
- Kidney function(Up to 12 weeks)
- Hunger/satiety(Up to 12 weeks)
- Satiety indicators(Up to 12 weeks)
- Abdominal symptoms(12 weeks)
- Dietary intake data(Up to 12 weeks)
- Body mass index (BMI)(Up to 12 weeks)
- Body composition(Up to 12 weeks)
- Leptin(Up to 12 weeks)
- Waist circumference(Up to 12 weeks)
- Blood pressure(Up to 12 weeks)
- Homeostasis model assessment of insulin resistance (HOMA-IR)(12 weeks)
- Blood Lipid levels(Up to 12 weeks)
- Change in Quality of life(Up to 12 weeks)
- Liver function(Up to 12 weeks)
- Urine(Up to 12 weeks)
- Complete blood count(Up to 12 weeks)
- Stool(Up to 12 weeks)
- Inflammatory biomarkers(Up to 12 weeks)
- Physical activity(Up to 12 weeks)