Recruiting

Potatoes & Protein

Sponsor:

University of Toronto

Code:

NCT05610124

Conditions

Glycemic Control

Satiety Response

Appetite Regulation

Diabetes

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Ad libitum full-fat French fries with beef meatballs

Ad libitum instant mashed potatoes with beef meatballs

Ad libitum macaroni pasta with beef meatballs

Ad libitum full-fat French fries with vegetarian substitute meatballs

Ad libitum instant mashed potatoes with vegetarian substitute meatballs

Study Details

Brief summary:

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.

Conditions

Glycemic Control

Satiety Response

Appetite Regulation

Diabetes

Obesity

Study ID

NCT05610124

Start date

Feb 1, 2023

Status verified date

Jun, 2023

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • > 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.

Exclusion Criteria:

  • Smoking
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ad libitum full-fat French fries with beef meatballs

Ad libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with beef meatballs (25 g protein)

experimental: Ad libitum instant mashed potatoes with beef meatballs

Ad libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with beef meatballs (25 g protein)

experimental: Ad libitum macaroni pasta with beef meatballs

Ad libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with beef meatballs (25 g protein)

experimental: Ad libitum full-fat French fries with vegetarian substitute meatballs

Ad libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with vegetarian substitute meatballs (25 g protein)

experimental: Ad libitum instant mashed potatoes 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)

experimental: Ad libitum macaroni pasta with vegetarian substitute meatballs

Ad libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with vegetarian substitute meatballs (25 g protein)

Interventions

Ad libitum full-fat French fries with beef 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.

Ad libitum instant mashed potatoes with beef 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 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.

Ad libitum macaroni pasta with beef 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 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.

Ad libitum full-fat French fries 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 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.

Ad libitum instant mashed potatoes 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 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.

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 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.

Primary outcome measure

  • Change in Blood Glucose Levels [ 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 [ Time Frame: After 30 minutes of the treatment meal start. ]

Central Contacts and Locations

Central contacts

Amira Amr, PhD

6478645258amira.amr@utoronto.ca

Hrvoje Fabek, PhD

(416) 978-0799hrvoje.fabek@utoronto.ca

Locations

University of Toronto - Department of Nutritional Sciences

Recruiting

Toronto, Ontario, Canada, M5S 3E2

Contacts

Amira Amr, PhD

6478645258amira.amr@utoronto.ca

Hrvoje Fabek, PhD

(416) 978-0799hrvoje.fabek@utoronto.ca

Principal Investigator:

G. Harvey Anderson, PhD

More Information

Sponsor

University of Toronto

Last update posted

Jun 26, 2023

Last verified

Jun, 2023

Keywords

  • Glycemic Control
  • Satiety
  • Appetite
  • Potato
  • Protein quality
  • Blood glucose
  • Insulin
  • Ghrelin
  • Nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Toronto on 2023-06-26.