Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidade Nova de Lisboa

About this trial

The proposed study aims to evaluate the impact on intestinal and oral microbiota composition and the metabolic effects of the daily consumption of a wheat-based fermented beverage, developed under the collaborative WHEATBIOME project, over a 4-week intervention period in healthy adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body Mass Index (BMI) between 18.5 and 24.9 kg/m²

Healthy status

Willingness to consume a fermented wheat-based beverage daily for 4 weeks

Capacity and willingness to provide written informed consent

Disqualifiers

Use of antibiotics and/or probiotics in the 12 weeks prior to the study

Weight variation >10% within the last 3 months

Participation in any clinical study or trial within the previous 12 months

Diagnosed medical conditions, including: diabetes, liver disease (e.g., cirrhosis), pancreatitis or other malabsorption syndromes, gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease), history of weight-loss surgery (e.g., bariatric surgery), chronic respiratory, neurological, psychiatric, musculoskeletal, or other systemic conditions, eating disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • Wheat-based fermented beverage

    Other intervention

    Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gut microbiota

Changes in gut microbiota from baseline. Microbial DNA will be extracted from faecal samples and sequenced by shotgun metagenomics. All the identified bacterial phyla, genus and species will be expressed in percentage.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
2

Oral microbiota

Changes in oral microbiota from baseline. Microbial DNA will be extracted from buccal swabs and sequenced by shotgun metagenomics. All the identified bacterial phyla, genus and species will be expressed in percentage.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
3

Fasting blood glucose

Changes in fasting blood glucose levels (mg/dL) levels from baseline.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
4

Insulin

Changes in insulin levels (μU/mL) levels from baseline.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Secondary outcomes

1

Weight

Changes in weight (kg) from baseline.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
2

Body fat mass

Changes in percentage of body fat mass from baseline.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
3

Gastrointestinal quality of life

Changes in gastrointestinal quality of life by the Gastrointestinal Quality of Life Index (GIQLI) questionnaire from baseline. The GIQLI is a 36 -item questionnaire and consists of 5 different subscales. The total score is calculated as the sum of the 36 items each ranged from 0 to 4. The final score range from 0 to 144 points (lower scores indicate more unfavorable conditions).

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
4

Interleukin-6

Changes in interleukin-6 (pg/mL) from baseline.

Time frame
At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Other outcomes

Sponsors and contacts

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