An interventional study of Ad libitum full-fat French fries with beef meatballs and Ad libitum instant mashed potatoes with beef meatballs in Glycemic Control, Satiety Response and Appetite Regulation, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by University of Toronto · Not applicable, Interventional, and Prevention
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.
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:
Primary objective:
To investigate the effects of potato consumption served with either meat or vegetarian substitute "meat" on meal-time FI and PPG, insulin, satiety and FI compensation at a later meal in healthy and normal weight adults. FI and PPG are primary outcomes and satiety, insulin, active ghrelin, amino acid response and FI compensation are secondary outcomes.
Specific Objectives:
Objective 1: To simulate at home-style meals and determine their effects on FI, satiety, PPG, and insulin, over three hours. Meals will be served with 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.
Objective 2: To determine the effect of at home-style meals with beef or a vegetarian substitute with mashed potatoes on FI compensation at an ad libitum pizza meal 3h later. Post-meal PPG and satiety will be measured for one hour.
Objective 3: To compare the amino acid response for 3 h after the meat and vegetarian based meals served with mashed potatoes, French fries, or pasta.
University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ad libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with beef meatballs (25 g protein)
Other: Ad libitum full-fat French fries with beef meatballs
Ad libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with beef meatballs (25 g protein)
Other: Ad libitum instant mashed potatoes with beef meatballs
Ad libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with beef meatballs (25 g protein)
Other: Ad libitum macaroni pasta with beef meatballs
Ad libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with vegetarian substitute meatballs (25 g protein)
Other: Ad libitum full-fat French fries with vegetarian substitute meatballs
Ad libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with vegetarian substitute meatballs (25 g protein)
Other: Ad libitum instant mashed potatoes with vegetarian substitute meatballs
Ad libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with vegetarian substitute meatballs (25 g protein)
Other: Ad libitum macaroni pasta with vegetarian substitute meatballs
Participants will consume 1 of the 6 treatment meals at each of the 6 study sessions in random orders such that by the end of the study, they will have consumed all 6 treatments. Participants will be given 30 minutes to consume the treatment meal and will be instructed to eat all the meatballs but to eat the French fries ad libitum (250 g), until comfortably full, simulating "at home" meal consumption. After providing the participants with the first plate of 250 g French fries and about 120 g meatballs (25 g protein), additional plates of freshly cooked French fries (250 g) alone will be provided 10 and 20 min later and they will be given 30 min to complete the treatment meal. Each treatment will be served with water.
Participants will consume 1 of the 6 treatment meals at each of the 6 study sessions in random orders such that by the end of the study, they will have consumed all 6 treatments. Participants will be given 30 minutes to consume the treatment meal and will be instructed to eat all the meatballs but to eat the mashed potatoes ad libitum (250 g), until comfortably full, simulating "at home" meal consumption. After providing the participants with the first plate of 250 g mashed potatoes and about 120 g meatballs (25 g protein), additional plates of freshly cooked mashed potatoes (250 g) alone will be provided 10 and 20 min later and they will be given 30 min to complete the treatment meal. Each treatment will be served with water.
Participants will consume 1 of the 6 treatment meals at each of the 6 study sessions in random orders such that by the end of the study, they will have consumed all 6 treatments. Participants will be given 30 minutes to consume the treatment meal and will be instructed to eat all the meatballs but to eat the macaroni pasta ad libitum (250 g), until comfortably full, simulating "at home" meal consumption. After providing the participants with the first plate of 250 g macaroni pasta and about 120 g meatballs (25 g protein), additional plates of freshly cooked macaroni pasta (250 g) alone will be provided 10 and 20 min later and they will be given 30 min to complete the treatment meal. Each treatment will be served with water.
Participants will consume 1 of the 6 treatment meals at each of the 6 study sessions in random orders such that by the end of the study, they will have consumed all 6 treatments. Participants will be given 30 minutes to consume the treatment meal and will be instructed to eat all the meatballs but to eat the French fries ad libitum (250 g), until comfortably full, simulating "at home" meal consumption. After providing the participants with the first plate of 250 g French fries and about 120 g vegetarian "meatballs" (25 g protein), additional plates of freshly cooked French fries (250 g) alone will be provided 10 and 20 min later and they will be given 30 min to complete the treatment meal. Each treatment will be served with water.
Participants will consume 1 of the 6 treatment meals at each of the 6 study sessions in random orders such that by the end of the study, they will have consumed all 6 treatments. Participants will be given 30 minutes to consume the treatment meal and will be instructed to eat all the meatballs but to eat the mashed potatoes ad libitum (250 g), until comfortably full, simulating "at home" meal consumption. After providing the participants with the first plate of 250 g mashed potatoes and about 120 g vegetarian "meatballs" (25 g protein), additional plates of freshly cooked mashed potatoes (250 g) alone will be provided 10 and 20 min later and they will be given 30 min to complete the treatment meal. Each treatment will be served with water.
Participants will consume 1 of the 6 treatment meals at each of the 6 study sessions in random orders such that by the end of the study, they will have consumed all 6 treatments. Participants will be given 30 minutes to consume the treatment meal and will be instructed to eat all the vegetarian meatballs but to eat the macaroni pasta ad libitum (250 g), until comfortably full, simulating "at home" meal consumption. After providing the participants with the first plate of 250 g macaroni pasta and about 120 g meatballs (25 g protein), additional plates of freshly cooked macaroni pasta (250 g) alone will be provided 10 and 20 min later and they will be given 30 min to complete the treatment meal. Each treatment will be served with water.
Change in Blood Glucose Levels
Blood glucose level (mmol/L) is measured using finger prick capillary blood samples or intravenous blood samples.
Time frame: 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).
Food Intake
Food intake at the treatment meal time will be measured by weighing the carbohydrates (CHO) sides plates after the assigned meal time.
Time frame: After 30 minutes of the treatment meal start.
Change in Insulin Levels
Level of blood insulin (μU/mL) is measured using finger prick capillary blood samples or intravenous blood samples.
Time frame: 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
Active ghrelin hormone concentrations (μmol/L) is analyzed in intravenous blood samples.
Time frame: 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)
Amino acid concentrations (μmol/L) is analyzed in intravenous blood samples to determine amino acid release.
Time frame: 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).
Food Intake Compensation
The food intake compensation after the second meal (ad libitum pizza meal) will be measured (g).
Time frame: at 180 minutes after the treatment meals.
Change in Subjective Appetite
Motivation to Eat Adaptive Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Time frame: up to 180 - 240 minutes (time of completion of each session)
Change in Physical comfort
Physical Comfort Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Time frame: up to 180 - 240 minutes (time of completion of each session)
Change in Energy Level
Energy Level Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Time frame: up to 180 - 240 minutes (time of completion of each session)
Treatment palatability
Treatment Palatability Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Time frame: Immediately after treatment meal consumption
Change in Fatigue Level
Fatigue Level Visual Analogue Scales measured based on a score between 0 to 100. A higher score indicates higher outcome.
Time frame: up to 180 - 240 minutes (time of completion of each session)
Plan to share: No
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