Actively Recruiting
Effects of Omeprazole Ingestion on Postprandial Amino Acid Concentrations in Response to a Mixed Meal: A Pilot Study
Led by McGill University · Updated on 2026-02-06
4
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
McGill University
Lead Sponsor
B
BIO-CAT, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how omeprazole, a common stomach acid reducer, affects the levels of amino acids in the blood after eating a mixed meal. This study focuses on adults aged 50 to 60 years, as older adults may need more protein to support muscle health. Understanding if omeprazole changes amino acid absorption could help improve dietary recommendations for those taking this medication. Participants will take either a 20 mg omeprazole capsule or a placebo capsule daily for five days before each study visit. On the study day, they will take the dose again while consuming a standardized mixed meal containing chicken, peas, potatoes, and butter. The study uses a randomized, crossover design where each participant undergoes two visits at least one week apart, receiving omeprazole in one visit and placebo in the other. During each visit, blood samples will be collected before the meal and at multiple time points up to 300 minutes afterward to measure amino acid levels and other related markers. Researchers will assess how omeprazole affects post-meal amino acid concentrations and digestion. Participants will complete questionnaires on gastrointestinal tolerance, and safety will be monitored for up to 120 days after treatment. The total participation period includes these two visits and follow-up monitoring.
CONDITIONS
Brief Title
Effects of Omeprazole Ingestion on Postprandial Amino Acid Concentrations in Response to a Mixed Meal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 50 to 60 years at screening
- Body mass index (BMI) between 18.5 and 29.9 kg/m2 at screening
- Good general health with no uncontrolled diseases or conditions
- Stable use of medications, supplements, diet, lifestyle, and body weight for at least 3 months before screening
- Agree to avoid strenuous exercise 48 hours before each study visit
- Willing to limit alcohol intake to no more than 3 standard drinks daily and avoid alcohol 48 hours before visits
- Willing to maintain current cannabinoid use if applicable
- Able and willing to consent, understand questionnaires, and complete study procedures
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during the study
- Following diets restricting dairy products (e.g., vegan)
- Known allergy or intolerance to study products or their ingredients
- Weight change over 3 kg within 3 months before first visit
- Currently on or planning weight loss programs during the study
- Recent COVID-19 vaccination, current COVID-19 infection, or post-COVID-19 conditions
- Recent acute gastrointestinal illness within 2 weeks before screening
- History of gastrointestinal diseases like IBS, IBD, celiac disease, ulcers, pancreatitis, or eating disorders
- History of intestinal or bariatric surgery other than appendectomy or herniorrhaphy
- Difficulty swallowing or digestive tract obstruction
- Recent upper GI endoscopy or colonoscopy within 3 months before screening
- Diagnosed hypercholesterolemia, hypertriglyceridemia, cardiovascular, kidney, liver, or thyroid diseases
- Diabetes or pre-diabetes
- Major psychiatric or immune disorders
- Recent cancer diagnosis within 5 years (except localized skin or cervical cancer)
- Major surgery within 3 months before screening or planned during study
- History of substance or alcohol abuse within past year
- Participation in other research with test products recently
- Tobacco use within last 6 months
- Recent blood or plasma donation beyond specified amounts
- Any unstable medical condition or medication use posing risk or affecting study participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment period lasts 6 days (5 days prior plus the study day), repeated for each intervention in the crossover design.
Participants will consume one dose of Omeprazole 20mg or placebo capsule daily for 5 days prior to each study visit. On the study visit days, participants will consume a dose in the laboratory and take another dose with a standardized mixed meal.
2 study visits (in-person) with drug administration and blood draws over 5 hours post-meal
Trial Site Locations
Total: 1 location
1
McGill University
Montreal, Quebec, Canada, H2W 1S4
Actively Recruiting
Research Team
T
Tyler Churchward-Venne, PhD
D
Damian Papadopoulos, B.Sc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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