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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Wheat-based fermented beverage
Other interventionDaily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Fasting blood glucose
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Insulin
Changes in insulin levels (μU/mL) levels from baseline.
Secondary outcomes
Weight
Changes in weight (kg) from baseline.
Body fat mass
Changes in percentage of body fat mass from baseline.
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).
Interleukin-6
Changes in interleukin-6 (pg/mL) from baseline.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: