NCT06593769已完成不适用
Glycemic and Appetite Effects of a Pre-meal Whey-Protein Microgel (the GAP Study)
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年10月9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
- 18
- 试验地点
- 2
- 主要终点
- Post-prandial glucose - by continuos glucose measurement software
研究概览
简要总结
In this study, the investigators want to assess the effects of a short-term twice daily pre-meal consumption of a liquid whey-protein microgel formulation, when compared to placebo (i.e., water), on:
- post-prandial glucose
- appetite This is an open-label study in 18 overweight or obese participants. This study will be performed in one center, the Clinical Innovation Laboratory (CIL), Nestlé Research, Lausanne. Participants will be screened and randomly assigned to 1 of 2 sequences of consumption. Enrolled participants will then consume the test product, or placebo, pre-breakfast and pre-lunch for four days and then crossover to the other product, over a period of 12 days.
详细描述
This study aims to provide new insights, and confirm a number of previous observations related to the role of whey-protein microgel in supporting glycemic regulation and supporting appetite regulation in people with overweight or obesity.
- Primary objective: The primary objective is to assess the effect of a pre-meal intake of whey-protein microgel (WPM) versus placebo on post-prandial glucose (PPG) response after a standardized breakfast meal in participants with BMI of 27 - 35 kg/m2, aged between 45 and 70 years.
Primary endpoint:
The primary endpoint is the 2-hour iAUC postprandial glucose (PPG) excursion induced by a standardized breakfast with pre-breakfast (-15 min) WPM compared to placebo.
- Secondary objectives: The secondary exploratory objective is to compare the effect of pre-meal (-15 min) intake (at breakfast and lunch) of WPM versus placebo on appetite and further glycemic parameters in participants with BMI of 27 - 35 kg/m2, aged between 45 and 70 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 45 - 70 years, at enrolment.
- •Body mass index (BMI) ≥ 27 kg/m² but < 35 kg/m².
- •Healthy participants based on medical history.
- •Able to understand and to sign a written informed consent prior to study enrolment.
- •Willing and able to comply with the requirements for participation in this study.
排除标准
- •Any past or on-going diagnosed medical/surgical condition (i.e., diabetes, malignancy, gastrointestinal disease, chronic inflammatory condition, chronic kidney disease, cardiovascular disease, bleeding disorder) and/ or psychiatric condition (e.g. depression, psychotic disorders, chronic insomnia, eating disorder), which in the opinion of the site physician/investigator may risk participant's well-being/safety, impede participant compliance with study procedures or ability to complete the study and/or could confound the primary objectives of the study.
- •Random plasma glucose ≥ 11.1 mmol/L or fasting plasma glucose ≥ 7.0 mmol/L (finger-prick point-of-care [POC] testing)
- •HbA1c ≥ 6.5% (finger-prick POC testing)
- •Known inborn errors of amino acid and protein metabolism.
- •With planned/scheduled medical imaging procedure/s (magnetic resonance imaging [MRI], computed tomography [CT] scan, X-ray), or electrical heat (diathermy) treatment during the study period.
- •Known or suspected allergies or intolerances to any of the ingredients of the nutritional formulation (i.e., milk, lactose) and the study meals.
- •Known or suspected cutaneous hypersensitivity to adhesives, silicon, or plaster.
- •Substantial changes in eating habits (i.e., switching from one dietary regimen to another) up to 30 days before enrolment.
- •Anticipated change in usual physical activity levels during the study period (e.g., plans for undertaking new vigorous-intensity physical activity such as: jogging, running, carrying heavy objects or other loads upstairs, shoveling snow, participating in a fitness class, and fast swimming, that will lead to hard and fast breathing).
- •Any chronic alcohol or drug abuse within the past year; specifically, alcohol intake > 2 servings per day for males and >1 serving per day for females. A serving corresponds to 0.35dl of liquor/strong alcohol, 1 dl of wine, or 3 dl of beer.
- •Female participants who are pregnant, lactating and/or breastfeeding.
- •Participants who refuse to be informed of incidental findings relevant to their health (e.g. abnormal laboratory results).
- •Currently participating in another interventional study.
- •Family or hierarchical relationships with the research team members.
结局指标
主要结局
Post-prandial glucose - by continuos glucose measurement software
时间窗: V2 (day 1), V3 (day 5), V4 (day 12)
The effect of a pre-meal intake of WPM versus placebo on PPG response after a standardized meal in participants with BMI of 27 - 35 kg/m2.
次要结局
- Appetite regulation - through a VAS questionnaire(V2 (day 1), V3 (day 5), V4 (day 12))
- Appetite regulation - composite score - through a VAS questionnaire(V2 (day 1), V3 (day 5), V4 (day 12))
- Ad libitum food intake - weighted on the scale(V2 (day 1), V3 (day 5), V4 (day 12))
- Effect of the intervention on the post-prandial glucose after an ad libitum lunch(V2 (day 1), V3 (day 5), V4 (day 12))
- Mean daily glucose, intervention vs placebo - by continuos glucose measurement software(Day 2 (08:00 AM) to day 5 (08:00 AM) (3 days in total))
- Glucose stability, intervention vs placebo - by continuos glucose measurement software(Day 2 (08:00 AM) to day 5 (08:00 AM) (3 days in total))
- Glucose stability, intervention vs placebo, only breakfast/lunch - by continuos glucose measurement software(Day 2 (08:00 AM) to day 5 (08:00 AM) (3 days in total))
- Anthropometric measurements: weight - through a scale(V2 (day 1))
- Anthropometric measurements: height - through a scale(V2 (day 1))
- Subgroup analysis by Body Mass Index (BMI) (kg/m^2)(Through the study, from V2 until V4 (12 days in total))
研究者
研究点 (2)
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