Effects of Cocoa Solids on Gastrointestinal Transit, Postprandial Sensation and Gastrointestinal Well-being: a Randomized, Controlled Trial in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Gastric emptying half time
研究概览
简要总结
This is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids on gastrointestinal transit, post-prandial sensation and well-being. Additionally functional brain imaging will be applied to identify regions of brain that are activated or inactivated by cocoa ingestion. Healthy subjects will be recruited and randomized to receive either dark chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal diet in randomized order. Reference standard methodology will be applied to measure gastric emptying, oro-caecal and colonic transit time. Dark and white chocolate (100g, ~500kcal, ~50% fat) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity using FDG-Positron Emission Tomography. Additionally colonic transit will be assessed based on the number and distribution of radio-opaque markers in the colon. On the fourth day gastric emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a dark or white chocolate mousse test meal (both 150g, ~500kcal, ~50% fat). During both interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and mood will be recorded. Additionally, validated questionnaires will assess digestive comfort and well-bring at the end of each study day. These results will deliver comprehensive information about the effects of cocoa on gastrointestinal transit and sensation.
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
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers (men and women)
- •aged 18-65 years
- •body mass index 18-30kg/m2.
排除标准
- •special dietary requirements incompatible with dietary intervention (food allergies or intolerances)
- •clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that preclude intake of test meals
- •participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable)
- •individuals unwilling to provide written informed consent
- •inability to follow the procedures of the study, e.g. due to language problems (all study documents in English)
研究组 & 干预措施
Dark chocolate: FDG-PET
100 g dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity and colonic transit using chocolate: fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
干预措施: Dark chocolate bar (Dietary Supplement)
Dark chocolate: Physiological Measurement
150 g dark chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy.
干预措施: Dark chocolate mousse (Dietary Supplement)
White chocolate: FDG-PET
100 g white chocolate bar (0% cocoa solids (~500kcal, 50% fat) will be consumed with radio-opaque markers on three consecutive days. On the third day chocolate ingestion will be followed by measurements of postprandial brain activity and colonic transit using FDG-Positron Emission Tomography.
干预措施: White chocolate bar (Dietary Supplement)
White chocolate: Physiological Measurement
150 g white chocolate mousse (~500kcal, ~50% fat) labelled with 13C-lactose-ureide and technetium (99Tc) will be consumed to assess gastric emptying and oro-caecal transit time by scintigraphy.
干预措施: White chocolate mousse (Dietary Supplement)
结局指标
主要结局
Gastric emptying half time
时间窗: Baseline until 2 hours postingestion
assessed by scintigraphy
次要结局
- Oro-caecal transit time (OCTT)(Baseline until 3 hours postingestion)
- Colonic transit time(Baseline until 3 days after ingestion)
- Post-prandial satiety(changes from baseline to three hours after treatment)
- Gastrointestinal well-being(changes from baseline to three hours after treatment)
