Postprandial Glycemia and Satiety of Meals With Potatoes, With and Without Protein
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
November 9, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedJune 26, 2023
June 1, 2023
11 months
October 24, 2022
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Blood Glucose Levels
Blood glucose level (mmol/L) is measured using finger prick capillary blood samples or intravenous blood samples.
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.
After 30 minutes of the treatment meal start.
Secondary Outcomes (9)
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).
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)
- +4 more secondary outcomes
Study Arms (6)
Ad libitum full-fat French fries with beef meatballs
EXPERIMENTALAd libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with beef meatballs (25 g protein)
Ad libitum instant mashed potatoes with beef meatballs
EXPERIMENTALAd libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with beef meatballs (25 g protein)
Ad libitum macaroni pasta with beef meatballs
EXPERIMENTALAd libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with beef meatballs (25 g protein)
Ad libitum full-fat French fries with vegetarian substitute meatballs
EXPERIMENTALAd libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with vegetarian substitute meatballs (25 g protein)
Ad libitum instant mashed potatoes with vegetarian substitute meatballs
EXPERIMENTALAd libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with vegetarian substitute meatballs (25 g protein)
Ad libitum macaroni pasta with vegetarian substitute meatballs
EXPERIMENTALAd libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with vegetarian substitute meatballs (25 g protein)
Interventions
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.
Eligibility Criteria
You may qualify if:
- \> 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Alliance for Potato Research and Educationcollaborator
Study Sites (1)
University of Toronto - Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2, Canada
Related Publications (1)
Amr AM, Anderson GH, Vien S, Fabek H. Potatoes Compared with Rice in Meals with either Animal or Plant Protein Reduce Postprandial Glycemia and Increase Satiety in Healthy Adults: A Randomized Crossover Study. J Nutr. 2024 Oct;154(10):2999-3011. doi: 10.1016/j.tjnut.2024.08.017. Epub 2024 Aug 23.
PMID: 39182847DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
G. Harvey Anderson, PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2022
First Posted
November 9, 2022
Study Start
February 1, 2023
Primary Completion
December 31, 2023
Study Completion
April 30, 2024
Last Updated
June 26, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share