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| Name | Class |
|---|---|
| BIO-CAT, Inc. | INDUSTRY |
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Omeprazole is a proton pump inhibitor commonly used to reduce stomach acid in the treatment of heartburn, gastroesophageal reflux disease, and gastric ulcers. By blocking the H⁺/K⁺-ATPase pumps in the gastric lining, it raises gastric pH and can alter the normal activation of pepsin, the enzyme responsible for beginning protein breakdown in the stomach.
Under normal conditions, dietary proteins are denatured by gastric acid and cleaved by pepsin into smaller peptides. These peptides enter the small intestine, where pancreatic enzymes (trypsin, chymotrypsin) and brush-border peptidases (aminopeptidase, dipeptidase) further hydrolyze them into free amino acids that are absorbed into the bloodstream. Suppressing stomach acidity may allow larger peptides to pass into the intestine, potentially reducing the efficiency of amino acid liberation and absorption.
In this randomized, crossover study, adults aged 50-60 years will attend two study visits at least one week apart. In one visit they will take a standard dose of omeprazole before consuming a mixed meal with a fixed protein content; in the other visit they will consume the same meal without medication. Blood samples will be collected before the meal and at multiple time points afterward to measure plasma amino acid concentrations and compare postprandial responses.
Older adults experience anabolic resistance, meaning they require higher protein intakes to stimulate muscle protein synthesis effectively. If omeprazole reduces amino acid availability after a meal, individuals taking this medication may need adjusted dietary protein recommendations. Findings from this study will help refine nutrition guidelines for people on proton pump inhibitors and support optimal muscle health and recovery in middle-aged and older adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole 20mg capsule | Active Comparator | Pharmaceutical Intervention: Omeprazole 20 mg capsule 1 dose = 1 capsule of Omeprazole 20mg 1 dose will be consumed per day for 5 days before the study visit. The participant will then also consume 1 dose on the day of the study visit in the laboratory environment. |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole 20 mg | Drug | Omeprazole 20mg capsule 1 dose = 1 capsule Participants will consume one dose per day for 5 days prior to their study visit. They will also consume one dose the day of the study visit in the laboratory setting. They will also consume one dose with the standardized mixed meal containing chicken, peas, potatoes, and butter the day of the study treatment visit in the laboratory. |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Area Under the Curve for Total Plasma Amino Acid Concentrations | Plasma total amino acid concentrations (µmol·L-¹) measured by LC-MS at each time point; iAUC calculated using the trapezoidal rule to quantify the postprandial rise in amino acids after a single mixed meal in the Omeprazole versus placebo condition. | 0-300 minutes post-meal (blood draws at baseline (0), 30, 60, 90, 120, 180, 240, and 300 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Total (0-5 hours) postprandial plasma branched chain amino acid concentration incremental area-under-the-curve | Free leucine, isoleucine, valine (combined) (µmol·L^(-1)·300 minutes) | 5 hours |
| Total (0-5 hours) postprandial plasma leucine concentration incremental area-under-the-curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tyler Churchward-Venne, PhD | Contact | 514-399-9684 | tyler.churchward-venne@mcgill.ca | |
| Damian Papadopoulos, B.Sc | Contact | 514-561-7860 | damian.papadopoulos@mail.mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University | Recruiting | Montreal | Quebec | H2W 1S4 | Canada |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Other | Placebo 1 dose of placebo = 1 capsule filled with maltodextrin Participants will consume 1 dose per day for 5 days prior to their study visit. They will then consume 1 dose the day of their study visit in the laboratory setting. They will also consume one dose with the standardized mixed meal containing chicken, peas, potatoes, and butter the day of the study treatment visit in the laboratory. |
|
Free leucine (µmol·L^(-1)·300 minutes) |
| 5 hours |
| Postprandial plasma amino acid maximum concentration | Total amino acids, essential amino acids, branched chain amino acids, leucine (µmol/L) | 5 hours |
| Postprandial plasma amino acid time to peak concentration | Total amino acids, essential amino acids, branched chain amino acids, leucine (minutes) | 5 hours |
| Postprandial plasma glucose concentration incremental area-under-the-curve | Plasma glucose (mmol·L^(-1)·300 minutes) | 5 hours |
| Postprandial plasma insulin concentration incremental area-under-the-curve | Plasma insulin (mmol·L^(-1)·300 minutes) | 5 hours |
| 8-Item Modified Gastrointestinal Tolerance Questionnaire scores | Participants will be asked to complete an 8-item modified Gastrointestinal Tolerance Questionnaire at the conclusion of each aminoacidemia trial (t = 4 hours). Gastrointestinal symptoms including abdominal bloating/distension, burping, gas/flatulence, borborygmus/stomach rumbling, abdominal cramping, reflux (heartburn), nausea, and vomiting, will be ranked on a 4-point scale ranging from "none" to "severe". | 5 hours |
| Accuracy of participant guesses for intervention order | At the end of the study, participants complete a brief survey indicating which intervention (Omeprazole or placebo) they believe they received in each arm. We will report the proportion of correct vs. incorrect guesses for visit 1 and visit 2 as a measure of blinding effectiveness. | Immediately after the second study visit (exit survey) |
| Incidence of adverse events | Number of participants with adverse events | 120 days |
| Incremental Area Under the Curve for Essential Plasma Amino Acid Concentrations | Plasma essential amino acid concentrations (µmol·L-¹) measured by LC-MS at each time point; iAUC calculated using the trapezoidal rule to quantify the postprandial rise in amino acids after a single mixed meal in the Omeprazole versus placebo condition. | 0-300 minutes post-meal (blood draws at baseline, 30, 60, 90, 120, 180, 240, and 300 minutes) |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |