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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Louvain-la-Neuve, Bélgica, 1348
- Center of Investigation in Clinical Nutrition (CICN)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Purple Bacteria Formulation
Participants will consume a protein-enriched dairy product containing purple bacteria.
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Approximately 50 g of purple bacteria incorporated into approximately 110 g of a protein-enriched dairy product.
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Comparador activo: Control Formulation
Participants will consume a protein-enriched dairy product without purple bacteria.
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160 g of protein-enriched dairy product.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in postprandial plasma essential amino acid concentrations (µmol/L)
Periodo de tiempo: Throughout the entire study, approxiamtely during 1 month
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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.
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Throughout the entire study, approxiamtely during 1 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in exhaled volatile organic compounds (VOCs) profile (relative abundance, arbitrary units)
Periodo de tiempo: Throughout the entire study, approxiamtely during 1 month
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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.
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Throughout the entire study, approxiamtely during 1 month
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Change in salivary gastrointestinal hormone concentrations (pg/mL)
Periodo de tiempo: Throughout the entire study, approxiamtely during 1 month
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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.
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Throughout the entire study, approxiamtely during 1 month
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Gastrointestinal symptom severity score assessed using a 5-point Likert scale (0-4)
Periodo de tiempo: Throughout the entire study, approxiamtely during 1 month
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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
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Number of participants with at least one adverse event
Periodo de tiempo: Throughout the entire study, approxiamtely during 1 month
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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.
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Throughout the entire study, approxiamtely during 1 month
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived stress score assessed using the Perceived Stress Scale (PSS-10; range 0-40)
Periodo de tiempo: Throughout the entire study, approxiamtely during 1 month
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sylvie Copine, Dr, Université Catholique de Louvain
- Investigador principal: Laurent Simar, Dr, Université Catholique de Louvain
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PROTEBOOST_BIODISPO1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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