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| Name | Class |
|---|---|
| University of Mons | OTHER |
| University of Liege | OTHER |
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This interventional clinical study aims to evaluate the bioavailability of amino acids derived from purple bacteria in healthy adults. Participants will consume either a protein-enriched dairy product or a protein-enriched dairy product containing purple bacteria during two separate test periods in a randomized cross-over design. Blood amino acid concentrations will be measured over a 4-hour postprandial period to assess amino acid absorption and bioavailability.
Additional biological samples including saliva, exhaled air, and feces will be collected to evaluate gastrointestinal hormones, volatilome profiles, and related metabolic responses.
Purple bacteria are recognized for their high-quality protein content, including essential amino acids, as well as their vitamin and carotenoid composition. However, limited data are available regarding the bioavailability of amino acids derived from purple bacteria in humans.
This randomized, open-label, cross-over study will enroll approximately 12 healthy adult participants in Belgium. Each participant will receive two dairy-based formulations in randomized order:
Control formulation: protein-enriched dairy product. Test formulation: protein-enriched dairy product containing purple bacteria.
The two intervention periods will be separated by a washout period of at least one week.
Participants will undergo one screening visit and two test visits. During each test visit, serial blood samples will be collected over 240 minutes following ingestion of the assigned formulation to determine plasma amino acid concentrations. Additional saliva, exhaled air, and fecal samples will also be collected.
The primary objective is to determine whether amino acids present in purple bacteria are better absorbed than amino acids from other protein sources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purple Bacteria Formulation | Experimental | Participants will consume a protein-enriched dairy product containing purple bacteria. |
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| Control Formulation | Active Comparator | Participants will consume a protein-enriched dairy product without purple bacteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purple Bacteria-Enriched Dairy Product | Dietary Supplement | Approximately 50 g of purple bacteria incorporated into approximately 110 g of a protein-enriched dairy product. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in postprandial plasma essential amino acid concentrations (µmol/L) | Plasma concentrations of essential amino acids (including leucine, isoleucine, valine, lysine, threonine, phenylalanine, methionine, tryptophan, and histidine) will be measured using LC-MS/MS at baseline and at multiple postprandial time points following ingestion of control and test formulations. Results will be reported as incremental area under the curve (iAUC, µmol/L·h) over the postprandial period. | Throughout the entire study, approxiamtely during 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exhaled volatile organic compounds (VOCs) profile (relative abundance, arbitrary units) | Exhaled air samples will be analyzed using gas chromatography-mass spectrometry (GC-MS). Specific VOCs will be quantified and reported as relative abundance (arbitrary units) and/or multivariate profile changes (e.g., PCA scores) comparing test vs control formulations. | Throughout the entire study, approxiamtely during 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress score assessed using the Perceived Stress Scale (PSS-10; range 0-40) | Perceived stress will be assessed using the Perceived Stress Scale (10-item version, PSS-10), a validated questionnaire measuring the degree to which situations in one's life are appraised as stressful. The total score ranges from: 0 to 40, with higher scores indicating higher perceived stress Results will be reported as: mean total PSS score change from baseline over the study period and/or between-group differences following ingestion of the study formulations. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Copine, Dr | Université Catholique de Louvain | Principal Investigator |
| Laurent Simar, Dr | Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Investigation in Clinical Nutrition (CICN) | Louvain-la-Neuve | 1348 | Belgium |
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Participants will receive both study formulations in randomized order over two intervention periods separated by a washout period of at least one week.
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| Protein-Enriched Dairy Product | Other | 160 g of protein-enriched dairy product. |
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| Change in salivary gastrointestinal hormone concentrations (pg/mL) | Salivary concentrations of gastrointestinal hormones (e.g., ghrelin, GLP-1, PYY) will be measured using immunoassays. Results will be expressed as change from baseline and iAUC (pg/mL·h) over the postprandial period. | Throughout the entire study, approxiamtely during 1 month |
| Gastrointestinal symptom severity score assessed using a 5-point Likert scale (0-4) | Gastrointestinal tolerance will be assessed using a standardized symptom questionnaire evaluating the severity of gastrointestinal symptoms (including bloating, abdominal pain, flatulence, nausea, and diarrhea). Each symptom will be rated using a 5-point Likert scale, defined as: 0 = not at all
Results will be reported as: mean gastrointestinal symptom score (average across symptoms) and/or total symptom score (sum of all items; higher scores indicate worse symptoms) and change from baseline over the postprandial period following ingestion of study formulations. | Throughout the entire study, approxiamtely during 1 month |
| Number of participants with at least one adverse event | Adverse events will be collected throughout the study period and reported as the number and proportion of participants experiencing at least one adverse event, by condition. | Throughout the entire study, approxiamtely during 1 month |
| Throughout the entire study, approxiamtely during 1 month |