NCT02979717已完成不适用
The Effect of a High Protein, High Fibre Shake Pre-load on Measures of Satiety and Subsequent Energy Intake in Healthy Overweight and Obese Subjects: An Acute Randomized, Crossover, Double-blind Placebo-controlled Study
Beachbody2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月23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
- 50
- 试验地点
- 2
- 主要终点
- Energy intake (total kilocalories) at meal subsequent to intervention pre-load
研究概览
简要总结
The objective of this study is to determine the effect of a high protein, high fiber supplement pre-load on energy intake at a subsequent meal compared to a low fiber, high carbohydrate Control product in healthy overweight and obese subjects. The investigators hypothesize the high protein, high fiber pre-load will result in reduced energy intake at a subsequent meal compared to low protein, low fiber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant, non-lactating females, 18-50 years of age, inclusive
- •Body mass index (BMI) between 27 and 33 kg/m² inclusive at screening.
- •Blood pressure < 130/
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- •Willing to abstain from strenuous exercise, consumption of alcoholic drinks and caffeine-containing food/drinks 24 hours before study days and during study days (until study completion for that day).
- •Willing to maintain current dietary supplement (if applicable) use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
- •Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
- •Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- •Female subjects are willing to use a contraceptive method to avoid pregnancy during the study period.
排除标准
- •Failure to meet any one of the inclusion criteria
- •Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
- •Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, blood thinners, diuretics, thiazolidinediones, metformin, antibiotics and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- •Major trauma or surgical event within 3 months of screening.
- •Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- •Known intolerance, sensitivity or allergy to any ingredients in the study products.
- •Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc)..
- •Change in body weight of >3.5kg within 4 weeks of the screening visit.
- •Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
- •History of cancer in the prior two years, except for non-melanoma skin cancer.
- •Exposure to any non-registered drug product within 30 d prior to screening.
- •Pregnancy or breastfeeding
- •Any history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating) diagnosed by a health professional
结局指标
主要结局
Energy intake (total kilocalories) at meal subsequent to intervention pre-load
时间窗: 1 hour post-intervention
Participants will consume an ad-libitum pizza meal for 30 minutes, 30 minutes following ingestion of the pre-load intervention. At the end of the 30 minute pizza meal, total caloric intake will be recorded.
次要结局
- Visual Analog Scale (VAS) Appetite Questionnaire on scale of 0-100(pre-intervention; 10, 20, 30, 60 min post-intervention)
- Subjective Physical Comfort Questionnaire on scale of 0-100(pre-intervention; immediately post-intervention; 30 min post-intervention)
- Visual Analog Scale (VAS) Cravings Questionnaire on scale of 0-100(pre-intervention; 10, 20, 30, 60 min post-intervention)
研究者
研究点 (2)
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