Status:

NOT_YET_RECRUITING

Protein Complementation of Plant-based Diets.

Lead Sponsor:

The Hospital for Sick Children

Conditions:

Each Participant Will be Studied Over 5 Dietary Periods, Each Over 9d

Eligibility:

All Genders

18-79 years

Phase:

NA

Brief 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...

Detailed Description

Complementation of plant proteins with complementary amino acid profile (cereal grain + legume) in each meal can improve the protein quality of plant based diets. However, some maintain that if a vari...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 30 2029

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07151625

Start Date

October 1 2025

End Date

September 30 2029

Last Update

September 3 2025

Active Locations (1)

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1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5S 1A8