A 64-week Pilot Trial to Evaluate the Effects of a Novel Nutraceutical on Weight Loss and Weight Loss Maintenance in Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Weight loss maintenance
研究概览
简要总结
The purpose of this 2-stage intervention study is to investigate the effect of a novel nutraceutical (containing tetrahydro iso-alpha acids derived from hops) on weight loss and weight loss maintenance in obese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 30 and ≤ 47
排除标准
- •Prohibited medications, supplements or herbal products
- •Use of narcotics, oral or injectable corticosteroids, multivitamin/multimineral supplements, antioxidant supplements, vitamin D supplements, probiotics and omega-3 fatty acid supplements 30 days prior to screening and for the duration of the study.
- •Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
- •Change in prescription, OTC, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
- •Medical history and concurrent diseases
- •Known allergy or hypersensitivity to study product or placebo.
- •Clinically significant abnormalities in medical history of physical examination.
- •Clinically relevant conditions expected to preclude achievement of exercise recommendation.
- •Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
- •Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, TB ,hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness.
- •Smoking or use of nicotine containing products within 30 days prior to screening and for the duration of the study.
- •Use of drugs of abuse (e.g. marijuana, cocaine, PCP, and methamphetamine) within 30 days prior to screening and for the duration of the study.
- •Other criteria
- •Initiation of a new or change of an existing exercise regiment within 30 days prior to screening.
- •Initiation of a new or change of an existing food plan within 30 days prior to screening.
研究组 & 干预措施
THIAA
Stage 1 (the first 12 weeks of the study): all subjects participate in a structured lifestyle change program featuring a high-protein, high-phytonutrient food plan (HP2). Those randomized to THIAA arm additionally receive the THIAA tablet, 3 times a day.
Stage 2 (the subsequent 52-week study): All qualified subjects (i.e. those who have lost at least 7.5% of their body weight in Stage 1) participate in a less restrictive lifestyle change program featuring a Mediterranean-style Low-glycemic-load food plan (MLGL). Those randomized to THIAA arm additionally receive the THIAA tablet, 3 times a day.
干预措施: THIAA (Dietary Supplement)
Placebo
Stage 1 (the first 12 weeks of the study): all subjects participate in a structured lifestyle change program featuring a high-protein, high-phytonutrient food plan (HP2). Those randomized to Placebo arm receive the placebo tablet, 3 times a day.
Stage 2 (the subsequent 52-week study): All qualified subjects (i.e. those who have lost at least 7.5% of their body weight in Stage 1) participate in a less restrictive lifestyle change program featuring a Mediterranean-style Low-glycemic-load food plan (MLGL). Those randomized to Placebo arm receive the placebo tablet, 3 times a day.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Weight loss maintenance
时间窗: Baseline, 64 weeks
The primary endpoint is the absolute pounds of weight change from baseline to the end of the 64 weeks.
次要结局
- Long-term THIAA effect(baseline, 64 weeks)
- Weight loss(12 weeks, 64 weeks)
- Short-term THIAA effect(Baseline, 12 weeks)