Evaluation of the Bioavailability of Amino Acids From Purple Bacteria (PROTEBOOST_1)
Evaluation of the Consumption of Fresh Purple Bacteria Biomass in Healthy Humans: Safety Test and Monitoring of Metabolism
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Louvain-la-Neuve, Belgique, 1348
- Center of Investigation in Clinical Nutrition (CICN)
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18 to 50 years
- Body mass index between 18 and 30 kg/m²
- Healthy participants
- Non-smokers
- Women of childbearing potential using effective contraception
- Able to understand and speak French
- Willing and able to comply with study procedures
Exclusion Criteria:
- Pregnancy or breastfeeding
- Use of medications or dietary supplements incompatible with study participation
- Any medical condition considered by the investigator to interfere with study participation or interpretation of results
- Vegan or vegetarian diets
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Purple Bacteria Formulation
Participants will consume a protein-enriched dairy product containing purple bacteria.
|
Approximately 50 g of purple bacteria incorporated into approximately 110 g of a protein-enriched dairy product.
|
|
Comparateur actif: Control Formulation
Participants will consume a protein-enriched dairy product without purple bacteria.
|
160 g of protein-enriched dairy product.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in postprandial plasma essential amino acid concentrations (µmol/L)
Délai: Throughout the entire study, approxiamtely during 1 month
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in exhaled volatile organic compounds (VOCs) profile (relative abundance, arbitrary units)
Délai: Throughout the entire study, approxiamtely during 1 month
|
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
|
|
Change in salivary gastrointestinal hormone concentrations (pg/mL)
Délai: Throughout the entire study, approxiamtely during 1 month
|
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)
Délai: Throughout the entire study, approxiamtely during 1 month
|
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
Délai: Throughout the entire study, approxiamtely during 1 month
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceived stress score assessed using the Perceived Stress Scale (PSS-10; range 0-40)
Délai: Throughout the entire study, approxiamtely during 1 month
|
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. |
Throughout the entire study, approxiamtely during 1 month
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sylvie Copine, Dr, Université Catholique de Louvain
- Chercheur principal: Laurent Simar, Dr, Université Catholique de Louvain
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PROTEBOOST_BIODISPO1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Volontaires en bonne santé
-
AstraZenecaParexelComplété