Postprandial Glycemia and Satiety of Meals With Potatoes, With and Without Protein
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Food Intake
研究概览
简要总结
The proposed study aims to simulate a meal eaten at home, where meals will provide a fixed amount of protein from beef or vegetarian substitute "meat" balls with ad libitum access to one of mashed potatoes, full-fat fries, or pasta. Postprandial glycemia (PPG), insulin, active ghrelin, satiety, amino acid response and food intake (FI) at the meal and again 3h later (after an ad libitum pizza meal) will be measured. In addition, post-meal PPG and satiety will be measured for one hour after the second meal.
详细描述
A total of 30 participants (15 males, 15 females) will be recruited in this study at the University of Toronto. Each participant will attend 6 study sessions where they will consume meals consisting of a fixed amount of beef or vegetarian substitute "meat" balls providing 25 g protein with ad libitum access to one of mashed potatoes, fried French fries, or pasta. Questionnaires will be filled out to assess their recent food intake, physical activity, sleep quality, stress level, appetite, physical comfort, and energy/fatigue level, as well as palatability of the food.
Blood samples will be collected at fasting and at various time points over a 3 hour period after eating the meals to measure blood glucose, insulin, active ghrelin and amino acid concentrations. After 3 hours, participants will receive an ad libitum pizza meal to assess their food intake compensation. Post-meal PPG and satiety will be measured for one hour after the pizza meal.
Study hypothesis:
- Consumption of potatoes in their most usual forms (mashed or deep fried), when compared with pasta in either meat or vegetarian based meals result in lower FI at the meal and lower PPG and insulin.
- Compensation for the reduced FI in the mashed potato meal does not occur at a pizza meal 3h later.
- Lower PPG and insulin post-test meal and second meal will be found.
- The amino acid profile of different meals will be reflected in post-prandial plasma levels and the amino acid response to vegetarian based meals with potatoes will be more balanced compared to the vegetarian based meals with pasta.
Primary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
True double blinding is not feasible in these study designs. Inherent differences in taste, smell, look and preparation of the various treatments are conspicuous and thus not possible to double-blind. This study is an ad libitum study to simulate a mealtime at home.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 and < 45 years of age
- •BMI > 18.5 and < 24.9 kg/m2
- •Willing to maintain habitual diet, physical activity pattern, and body weight throughout the study.
- •Willing to maintain current dietary supplement use throughout the study. On test days, subject agrees not to take any dietary supplements until dismissal from the Nutrition Intervention Center. Failure to comply will result in a rescheduled test visit.
- •Willing to abstain from alcohol consumption for 24h prior to all test visits.
- •Willing to refrain from marijuana/ edibles use for the duration of the study (approximately 6 weeks).
- •Willing to avoid vigorous physical activity for 24h prior to all test visits.
- •Understanding the study procedure and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
排除标准
- •Thyroid problems
- •Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, a malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
- •Presence of a gastrointestinal disorder or surgeries within the past year.
- •Known to be pregnant or lactating.
- •Unwillingness or inability to comply with the experimental procedures and to follow our safety guidelines.
- •Known intolerances, sensitivity or allergy to any ingredients in the study products.
- •Extreme dietary habits (i.e Atkins diet, very high protein diets, etc.) or restrained eaters, identified by a score of ≥ 11 on the Eating Habits Questionnaire
- •Uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg) as defined by the average blood pressure measured at screening.
- •Weight gain or loss of at least 10lbs in previous three months.
- •Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week).
- •Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment.
结局指标
主要结局
Food Intake
时间窗: After 30 minutes of the treatment meal start.
Food intake at the treatment meal time will be measured by weighing the carbohydrates (CHO) sides plates after the assigned meal time.
Change in Blood Glucose Levels
时间窗: Starting at the beginning of each session (0 minutes before consumption of treatment meal) and every 15-30 minutes up to 180 - 240 minutes (time of completion of each session).
Blood glucose level (mmol/L) is measured using finger prick capillary blood samples or intravenous blood samples.
次要结局
- Change in Fatigue Level(up to 180 - 240 minutes (time of completion of each session))
- Food Intake Compensation(at 180 minutes after the treatment meals.)
- Change in Subjective Appetite(up to 180 - 240 minutes (time of completion of each session))
- Change in Physical comfort(up to 180 - 240 minutes (time of completion of each session))
- Change in Insulin Levels(Starting at the beginning of each session (0 minutes before consumption of treatment meal) and every 30 minutes up to 180 - 240 minutes (time of completion of each session).)
- Change in Active Ghrelin Levels(Starting at the beginning of each session (0 minutes before consumption of treatment meal) and every 30 minutes up to 180 - 240 minutes (time of completion of each session).)
- Change in Amino Acid Response (Protein quality)(Starting at the beginning of each session (0 minutes before consumption of treatment meal) and every 30 minutes up to 180 - 240 minutes (time of completion of each session).)
- Change in Energy Level(up to 180 - 240 minutes (time of completion of each session))
- Treatment palatability(Immediately after treatment meal consumption)
研究者
G. Harvey Anderson
Professor
University of Toronto