Evaluation of the Bioavailability of Amino Acids From Purple Bacteria

NCT07613983 | Completed

• 1 other identifier: PROTEBOOST_BIODISPO1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Purple bacteria; Amino acid bioavailability; Protein absorption; Functional foods; Postprandial metabolism; Dairy product; Healthy adults

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in exhaled volatile organic compounds (VOCs) profile (relative abundance, arbitrary units)

  Throughout the entire study, approxiamtely during 1 month

• Change in salivary gastrointestinal hormone concentrations (pg/mL)

  Throughout the entire study, approxiamtely during 1 month

• Gastrointestinal symptom severity score assessed using a 5-point Likert scale (0-4)

  Throughout the entire study, approxiamtely during 1 month

• Number of participants with at least one adverse event

  Throughout the entire study, approxiamtely during 1 month

Other Outcomes (1)

• Perceived stress score assessed using the Perceived Stress Scale (PSS-10; range 0-40)

  Throughout the entire study, approxiamtely during 1 month

Study Arms (2)

Purple Bacteria Formulation

EXPERIMENTAL

Participants will consume a protein-enriched dairy product containing purple bacteria.

Dietary Supplement: Purple Bacteria-Enriched Dairy Product

Control Formulation

ACTIVE COMPARATOR

Participants will consume a protein-enriched dairy product without purple bacteria.

Other: Protein-Enriched Dairy Product

Interventions

Purple Bacteria-Enriched Dairy Product DIETARY_SUPPLEMENT

Approximately 50 g of purple bacteria incorporated into approximately 110 g of a protein-enriched dairy product.

Purple Bacteria Formulation

Protein-Enriched Dairy Product OTHER

160 g of protein-enriched dairy product.

Control Formulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mons: collaborator
• Université Catholique de Louvain: lead
• University of Liege: collaborator

Study Sites (1)

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, 1348, Belgium

Location

Study Officials

• Sylvie Copine, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Laurent Simar, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive both study formulations in randomized order over two intervention periods separated by a washout period of at least one week.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 29, 2026
• Study Start: April 13, 2026
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)