Ad libitum macaroni pasta with vegetarian substitute meatballs for Satiety Response

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Satiety Response+4 More
Ad libitum macaroni pasta with beef meatballs - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diabetes
  • Satiety Response
  • Obesity
  • Glycemic Control
  • 'Appetite Regulation'

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Immediately after treatment meal consumption

After 30 minutes of the treatment meal start.
Food Intake
Immediately after treatment meal consumption
Therapeutic procedure
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
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).
Ghrelin
Semen Quality
Insulin
at 180 minutes after the treatment meals.
Food Intake Compensation
up to 180 - 240 minutes (time of completion of each session)
Change in Energy Level
Change in Fatigue Level
Change in Physical comfort
Change in Subjective Appetite

Trial Safety

Trial Design

6 Treatment Groups

Ad libitum macaroni pasta with vegetarian substitute meatballs
1 of 6
Ad libitum macaroni pasta with beef meatballs
1 of 6
Ad libitum instant mashed potatoes with vegetarian substitute meatballs
1 of 6
Ad libitum full-fat French fries with beef meatballs
1 of 6
Ad libitum instant mashed potatoes with beef meatballs
1 of 6
Ad libitum full-fat French fries with vegetarian substitute meatballs
1 of 6
Experimental Treatment

30 Total Participants · 6 Treatment Groups

Primary Treatment: Ad libitum macaroni pasta with vegetarian substitute meatballs · No Placebo Group · N/A

Ad libitum macaroni pasta with vegetarian substitute meatballs
Other
Experimental Group · 1 Intervention: Ad libitum macaroni pasta with vegetarian substitute meatballs · Intervention Types: Other
Ad libitum macaroni pasta with beef meatballs
Other
Experimental Group · 1 Intervention: Ad libitum macaroni pasta with beef meatballs · Intervention Types: Other
Ad libitum instant mashed potatoes with vegetarian substitute meatballs
Other
Experimental Group · 1 Intervention: Ad libitum instant mashed potatoes with vegetarian substitute meatballs · Intervention Types: Other
Ad libitum full-fat French fries with beef meatballs
Other
Experimental Group · 1 Intervention: Ad libitum full-fat French fries with beef meatballs · Intervention Types: Other
Ad libitum instant mashed potatoes with beef meatballs
Other
Experimental Group · 1 Intervention: Ad libitum instant mashed potatoes with beef meatballs · Intervention Types: Other
Ad libitum full-fat French fries with vegetarian substitute meatballs
Other
Experimental Group · 1 Intervention: Ad libitum full-fat French fries with vegetarian substitute meatballs · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after treatment meal consumption

Who is running the clinical trial?

University of TorontoLead Sponsor
624 Previous Clinical Trials
718,923 Total Patients Enrolled
Alliance for Potato Research and EducationOTHER
12 Previous Clinical Trials
505 Total Patients Enrolled
G. Harvey Anderson, PhDPrincipal InvestigatorUniversity of Toronto
7 Previous Clinical Trials
397 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to maintain your current diet, physical activity pattern, and body weight throughout the study.
You are willing to maintain current dietary supplement use throughout the study
You are willing to abstain from alcohol consumption for 24h prior to all test visits.
You are willing to refrain from marijuana/ edibles use for the duration of the study.
You are willing to avoid vigorous physical activity for 24h prior to all test visits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.