Glycemic ControlNCT05610124
Postprandial Glycemia and Satiety of Meals With Potatoes, With and Without Protein
A study testing Ad libitum full-fat French fries with beef meatballs, Ad libitum instant mashed potatoes with beef meatballs and Ad libitum macaroni pasta with beef meatballs in people with Glycemic Control and Satiety Response, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Control, Satiety Response, Appetite Regulation
- What is being tested?
- Ad libitum full-fat French fries with beef meatballs, Ad libitum instant mashed potatoes with beef meatballs and Ad libitum macaroni pasta with beef meatballs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Toronto - Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
Amira Amr, PhD, 6478645258, amira.amr@utoronto.ca
Hrvoje Fabek, PhD, (416) 978-0799, hrvoje.fabek@utoronto.ca
About this study
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.
Read the detailed description
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:
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.
- Conditions
- Glycemic Control, Satiety Response, Appetite Regulation, Diabetes, Obesity
- Being tested
- 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
- Keywords
- Glycemic Control, Satiety, Appetite, Potato, Protein quality, Blood glucose, Insulin, Ghrelin, Nutrition
- Medical subject headings
- Diabetes Mellitus, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad libitum full-fat French fries with beef meatballsOther
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 meatballsOther
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 meatballsOther
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 meatballsOther
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 meatballsOther
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 meatballsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ad libitum full-fat French fries with beef meatballs | Experimental | Ad libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with beef meatballs (25 g protein) Receives: Other: Ad libitum full-fat French fries with beef meatballs |
| Ad libitum instant mashed potatoes with beef meatballs | Experimental | Ad libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with beef meatballs (25 g protein) Receives: Other: Ad libitum instant mashed potatoes with beef meatballs |
| Ad libitum macaroni pasta with beef meatballs | Experimental | Ad libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with beef meatballs (25 g protein) Receives: Other: Ad libitum macaroni pasta with beef meatballs |
| Ad libitum full-fat French fries with vegetarian substitute meatballs | Experimental | Ad libitum carbohydrate side with fixed amount of protein: Ad libitum full-fat French fries with vegetarian substitute meatballs (25 g protein) Receives: Other: Ad libitum full-fat French fries with vegetarian substitute meatballs |
| Ad libitum instant mashed potatoes with vegetarian substitute meatballs | Experimental | Ad libitum carbohydrate side with fixed amount of protein: Ad libitum instant mashed potatoes with vegetarian substitute meatballs (25 g protein) Receives: Other: Ad libitum instant mashed potatoes with vegetarian substitute meatballs |
| Ad libitum macaroni pasta with vegetarian substitute meatballs | Experimental | Ad libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with vegetarian substitute meatballs (25 g protein) Receives: Other: Ad libitum macaroni pasta with vegetarian substitute meatballs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose Levels
Blood glucose level (mmol/L) is measured using finger prick capillary blood samples or intravenous blood samples.
Measured: 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.
Measured: After 30 minutes of the treatment meal start.
Secondary outcomes (9)
Change in Insulin Levels
Level of blood insulin (μU/mL) is measured using finger prick capillary blood samples or intravenous blood samples.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 180 - 240 minutes (time of completion of each session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glycemic ControlStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study Design: The experiment follows a randomized, cross-over, repeated measures acute trial design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610124
- Sponsor's protocol ID
- 43406
- Status last verified
- Jun 2023
- First submitted
- 24 Oct 2022
- Last updated
- 26 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39182847
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glycemia and Satiety of Meals With Potatoes, With and Without Protein
- ClinicalTrials.gov ID
- NCT05610124
- Acronym / sponsor ID
- 43406
- Conditions
- Glycemic Control, Satiety Response, Appetite Regulation, Diabetes, Obesity
- Keywords
- Glycemic Control, Satiety, Appetite, Potato, Protein quality, Blood glucose, Insulin, Ghrelin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Alliance for Potato Research and Education
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Study Design: The experiment follows a randomized, cross-over, repeated measures acute trial design.
| Arm | Type | Receives |
|---|---|---|
| Ad libitum full-fat French fries with beef meatballs | Experimental | Other: Ad libitum full-fat French fries with beef meatballsAd 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 | Experimental | Other: Ad libitum instant mashed potatoes with beef meatballsAd 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 | Experimental | Other: Ad libitum macaroni pasta with beef meatballsAd 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 | Experimental | Other: Ad libitum full-fat French fries with vegetarian substitute meatballsAd 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 | Experimental | Other: Ad libitum instant mashed potatoes with vegetarian substitute meatballsAd 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 | Experimental | Other: Ad libitum macaroni pasta with vegetarian substitute meatballsAd libitum carbohydrate side with fixed amount of protein: Ad libitum macaroni pasta with vegetarian substitute meatballs (25 g protein) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- > 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad libitum full-fat French fries with beef meatballsParticipants 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. | Other | Ad libitum full-fat French fries with beef meatballs |
| Ad libitum instant mashed potatoes with beef meatballsParticipants 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. | Other | Ad libitum instant mashed potatoes with beef meatballs |
| Ad libitum macaroni pasta with beef meatballsParticipants 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. | Other | Ad libitum macaroni pasta with beef meatballs |
| Ad libitum full-fat French fries with vegetarian substitute meatballsParticipants 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. | Other | Ad libitum full-fat French fries with vegetarian substitute meatballs |
| Ad libitum instant mashed potatoes with vegetarian substitute meatballsParticipants 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. | Other | Ad libitum instant mashed potatoes with vegetarian substitute meatballs |
| Ad libitum macaroni pasta with vegetarian substitute meatballsParticipants 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. | Other | Ad libitum macaroni pasta with vegetarian substitute meatballs |
Primary outcome
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).
Blood glucose level (mmol/L) is measured using finger prick capillary blood samples or intravenous blood samples.
Food Intake
Time frame: 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.
9 secondary outcomes
Change in Insulin Levels
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
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)
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
Time frame: at 180 minutes after the treatment meals.
Change in Subjective Appetite
Time frame: up to 180 - 240 minutes (time of completion of each session)
Change in Physical comfort
Time frame: up to 180 - 240 minutes (time of completion of each session)
Change in Energy Level
Time frame: up to 180 - 240 minutes (time of completion of each session)
Treatment palatability
Time frame: Immediately after treatment meal consumption
Change in Fatigue Level
Time frame: up to 180 - 240 minutes (time of completion of each session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Derived from this study: PubMed 39182847Amr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Harvey Anderson, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ad libitum full-fat French fries with beef meatballs, Ad libitum instant mashed potatoes with beef meatballs and Ad libitum macaroni pasta with beef meatballs in people with Glycemic Control and Satiety Response, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Amr, PhD (6478645258, amira.amr@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.