Not Yet RecruitingNot Applicable

Protein Complementation of Plant-based Diets.

Canada40 participantsStarted 2025-10-01

Plain-language summary

Amino acids are the building blocks of proteins which are needed by the body for growth, and bodily functions. If even one amino acid is in short supply, this will negatively affect growth and various functions in the body. Animal foods like meat, fish and chicken contain all the amino acids needed by the body in the correct proportion. These foods are considered high quality protein foods. However plant proteins like lentils, wheat, rice are low in at least one amino acid. This means that plant proteins are considered low quality proteins. Data from the investigators lab and others show that when eating plant foods, combining grains and legumes like rice and beans, peanut butter and bread, (protein complementation) will provide a complete protein which contains all the amino acids needed by the body. However, some maintain that it is not necessary to combine foods like grains and legumes in the same meal as long as all the amino acids are consumed within a 24h period. This has never been tested. The goal of this study is to compare the effects non-complementation to protein complementization on whole body protein metabolism in young and older adults.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\) Young Adults: * Adults, age 18 - 39 yrs, Healthy with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes, Stable Body Weight (no more than 5 lb weight loss or gain in the past 3 months) * Not on any medications that could affect protein or amino acid metabolism e.g. steroids. * Fasting blood glucose, hemoglobin A1C (HbA1c), urea and creatinine within normal ranges for age. 2\) Older Adults: * Adults, aged 60-69 and 70-79 years, Healthy with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes, Stable Body Weight (no more than 5 lb weight loss or gain in the past 3 months) * Not on any medications that could affect protein or amino acid metabolism e.g. steroids, * Fasting blood glucose, hemoglobin A1C (HbA1c), urea and creatinine within normal ranges for age. Exclusion Criteria: * Unwillingness to participate or unable to tolerate the diet * Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients). * Significant caffeine consumption (\>2 cups per day) * Significant alcohol consumption (\>1 drink per day i.e. 1 beer or ½ glass of wine). * Fasting blood glucose, hemoglobin A1C (HbA1c), urea and creatinine outside of normal ranges for age. * On medications known to affect protein and AA metabolism, renal failure, liver disease, unable to ambulate independently.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Whole-body protein metabolism (WBPM): protein synthesis, protein breakdown and protein balance.

Timeframe: 9 days

Trial details

NCT IDNCT07151625

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-30

Contact for this trial

Mahroukh Rafii, BSc

416-813-7454 mahroukh.rafii@sickkids.ca

View on ClinicalTrials.gov More Each Participant Will be Studied Over 5 Dietary Periods, Each Over 9d trials