Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Gastric emptying time (minutes)
研究概览
简要总结
The wireless motility capsule technology, SmartPill™, can be used to assess gastric emptying and gastrointestinal (GI) transit time. The SmartPill is usually ingested together with a SmartBar™ which is a snack bar with a nutrient composition that differs substantially from a normal western diet. The primary aim of the present study is to compare effects of a SmartBar™ and a standard mixed meal on gastric emptying and GI motility.
详细描述
Background: The wireless motility capsule technology, SmartPill™, can be used to assess GI transit time including gastric emptying and small and large bowel transit time based on measurements of pH, pressure and temperature. The SmartPill™ allows for GI motility measurements under free-living conditions without radiation. The SmartPill is usually ingested together with a SmartBar™ which is a snack bar with a nutrient composition that differs substantially from a normal western diet. GI motility in response to meals plays an important role in regulation of e.g. appetite and glucose metabolism. Changes in appetite and metabolism in response to interventions are often assessed using a meal test and GI motility is assessed at the research facilities. The use of SmartPill™ in combination with a meal test would allow for assessment of GI motility under subsequent free-living conditions and improve our understanding of the effects of interventions on the integrative relationship between food intake, GI motility and metabolism. Most of our daily decisions and actions affecting energy intake are driven by the non-conscious processes; however, appetite is often assessed from participants' self-report which is associated with limitations such as desire to report socially desirable answers. Little is known about the complex interrelationship between biological markers of appetite e.g. GI hormones and subjective and objective measures of food related behavior under fasting and fed conditions.
The PRESET study has the following objectives:
- To compare effects of a SmartBar™ and a standard mixed breakfast meal on gastric emptying and GI transit time measured using the SmartPill™ in normal-weight individuals.
- To compare effects of a SmartBar™ and a standard mixed breakfast meal on concentrations of metabolites and pancreatic and GI hormones, and subjective and objective measures of appetite, food reward and food related behavior assessed from biometric responses (facial expression, galvanic skin response and eye tracking) to visual food stimuli varying in fat content and taste during the computerized Leeds Food Preference Questionnaire (LFPQ) in normal-weight individuals.
- To assess potential associations between gastric emptying and GI motility, biological markers of appetite and subjective appetite and objective measures of food related behavior from biometric responses to visual food stimuli during the LFPQ in the fasting state and in response to meals in normal-weight individuals.
Testing includes assessments in the fasting state and in response to consumption of the SmartBar™ and a standard mixed meal (4-hour meal tests and subsequent 6-days free-living assessment period) on two separate test days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index: 18.5 to 24.9 kg/m2
排除标准
- •Unable to understand the informed consent and the study procedures;
- •Self-reported history of an eating disorder in the past three years
- •Self-reported weight change (>5 kg) within three months prior to inclusion
- •HbA1c: ≥5.7 % (≥39 mmol/mol)
- •Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, GI or psychiatric disease; diabetes or other endocrine disease; immunosuppression
- •Current treatment with medication or medical devices which affect GI motility and transit time (prokinetics, antidiarrheals, laxatives)
- •Current treatment with medication which affect glucose metabolism or appetite
- •Current treatment with beta blockers or peroral steroids
- •Current treatment with non-steroidal anti-inflammatory drugs, tricyclic antidepressants, selective serotonin re-uptake inhibitors or opioids
- •Bariatric surgery
- •GI symptoms or diseases such as regular (weekly) abdominal pain, dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, celiac disease, Crohn's disease, ulcerative colitis or proctitis
- •Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion
- •Pregnant or lactating women
- •Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices
- •Concomitant participation in other research studies
研究组 & 干预措施
SmartBar™
The wireless capsule technology, SmartPill™, is usually ingested together with a SmartBar™ which is a snack bar with a nutrient composition that differs substantially from a normal western diet.
干预措施: SmartBar™ (Other)
Standard mixed breakfast meal
The SmartPill™ is ingested together with a standard mixed breakfast meal and the outcomes of interest will be compared with the SmartBar™ condition (reference).
干预措施: Standard mixed breakfast meal (Other)
结局指标
主要结局
Gastric emptying time (minutes)
时间窗: Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)
Measured by the SmartPill™ technique. The SmartPill™ is ingested at both visits in combination with the standard breakfast meal and SmartBar™, respectively. The time frame depends on the individual gastric emptying time.
次要结局
- Small bowel transit time (minutes)(Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively))
- Total gastrointestinal transit time (minutes)(Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively))
- Waist circumference (cm)(At 0 minutes (fasting) at both visits)
- Large bowel transit time (minutes)(Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively))
- Metabolites(0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Arousal measured using galvanic skin response(0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Emotions measured using facial expression analysis(0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Self-reported autonomic symptoms(Answered during test days (0-240 minutes))
- Fat percentage (%)(At 0 minutes (fasting) at both visits)
- Fat free mass (kg)(At 0 minutes (fasting) at both visits)
- Implicit wanting(0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Explicit liking(0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Subjective appetite(0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Fat mass (kg)(At 0 minutes (fasting) at both visits)
- Heart rate response to standing up from the supine position(At 0 minutes (fasting) at both visits)
- Body mass index (kg/m^2)(At 0 minutes (fasting) at both visits)
- Sleep onset latency (minutes)(Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Motility index (arbitrary unit)(Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively))
- Hormones(0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Attention measured using eye tracking(0 minutes (fasting) at 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Food choice(0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Self-reported gastrointestinal symptoms (part 1)(Answered during test days (0-240 minutes))
- Self-reported gastrointestinal symptoms (part 2)(Answered during test days (0-240 minutes))
- Explicit wanting(0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively))
- Self-reported gastrointestinal symptoms (part 3)(Registered 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Body weight (kg)(At 0 minutes (fasting) at both visits)
- Hip circumference (cm)(At 0 minutes (fasting) at both visits)
- Mean amplitude of glycaemic excursions (MAGE)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Continuous overall net glycaemic action (CONGA)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Mean glucose concentrations(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Resting energy expenditure (kcal/day)(At 0 minutes (fasting) at both visits)
- Substrate oxidation (respiratory exchange ratio)(At 0 minutes (fasting) at both visits)
- Physical activity energy expenditure (kcal/day)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Sleep timing (hh:mm)(Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Sleep variability (minutes)(Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Variation coefficients of glucose concentrations(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Systolic blood pressure (mmHg)(At 0 minutes (fasting) at both visits)
- Heart rate response to inhalation and exhalation(At 0 minutes (fasting) at both visits)
- Microbiome content and diversity(One sample during 6 days after both visits)
- Physical activity (time spent at different intensities)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Physical activity (counts/min)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Daily time spent above different glucose concentrations (e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Standard deviation of glucose concentrations(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Heart rate response to forced exhalation during rest (valsalva maneuver)(At 0 minutes (fasting) at both visits)
- Sleep duration (minutes)(Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Energy intake (kcal/day)(Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Diastolic blood pressure (mmHg)(At 0 minutes (fasting) at both visits)
- Heart rate (bpm)(At 0 minutes (fasting) at both visits)
- Physical activity (MET hours)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- HbA1c (mmol/mol and %)(At 0 minutes at both visits)
- Timing of physical activity (hh:mm)(Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Macronutrient intake (energy percentage)(Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Timing of dietary intake (hh:mm)(Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Wakefulness (minutes)(Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
- Insulin sensitivity (indices)(At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively)
- Insulin resistance (indices)(At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively)
- Sleep efficiency (%)(Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions))
研究者
Kristine Færch
Senior Researcher and Team Leader, PhD
Steno Diabetes Center Copenhagen