How a vegetarian diet affects digestion of pea protein in young and older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares pea protein digestion and metabolic use in four groups: young omnivores, young vegetarians, older omnivores, and older vegetarians, with four groups of 8 volunteers each. Peas are labeled with safe stable isotopes (15N and 2H) and participants attend two clinical investigation days separated by 4 weeks to 2 months. On the first day a 15N-labeled pea meal is consumed and blood is sampled over 8 hours with urine collections to measure postprandial nitrogen and protein metabolism, and on the second day amino acid digestibility of the pea protein is evaluated. Results will show how age and habitual diet influence plant protein bioavailability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Normal weight or overweight (18 \< BMI \< 30 kg·m-²)
* Male or female
* Aged 18-23 years (young groups) or 65-75 years (older groups)
* Following an omnivorous diet (regular consumption of meat products, with meat intake \> 3 times/week and \> 70% of protein intake from animal sources) or vegetarian diet (exclusion of meat and fish/seafood, with \> 70% of protein intake from plant sources)
* In good general health (WHO = 0)
* Affiliated with a social security system
* Free and informed consent, provided in writing after receiving the information required by the Public Health Code

Exclusion Criteria:

* Adults under legal protection or unable to give informed consent (e.g., under guardianship, trusteeship, or legal protection)
* Any known food allergy
* Positive serology for HBsAg, anti-HBc, HCV, or HIV
* Anemia: hemoglobin level \< 13 g/dL in men and \< 12 g/dL in women
* Pregnant women or those who may be pregnant (based on a positive urine pregnancy test at inclusion)
* Excessive alcohol consumption (\> 2 drinks/day). Harmful alcohol use will be assessed by the investigator at inclusion.
* Hypertension, diabetes, gastrointestinal, liver or kidney diseases, or severe heart disease. These conditions will be assessed by the investigator based on standard clinical evaluation and participants' self-reports at inclusion.
* Hypertension: significant arterial hypertension according to the investigator, or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at inclusion.
* Diabetes: type 1 or type 2 diabetes, or fasting blood glucose \> 1.25 g/L.
* Gastrointestinal disease: clinically significant gastrointestinal disorders (bleeding, vomiting, constipation/diarrhea grade \> 1) as judged by the investigator, any inflammatory bowel disease, or acute gastroenteritis in the month prior to the intervention.
* Liver disease: any significant hepatic disorder according to the investigator, or ASAT/ALAT \> 2.5 times the upper normal limit.
* High-level athletes (\> 8 hours of training per week)
* Blood donation within 8 weeks prior to study start
* Absence of free, informed, written consent after receiving the information required by the Public Health Code
* Not affiliated with a social security system

Where it's running

• Centre de Recherche sur Volontaire, Hopital Avicenne (AP-HP)
  Bobigny, France Recruiting

Study contacts

• Study coordinator: Juliane Calvez, PhD
• Email: juliane.calvez@agroparistech.fr
• Phone: +33189100875

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.