Wheat-based fermented beverage: Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Diagnosed food allergies or intolerances
* Pregnancy or breastfeeding
Primary outcome measure(s)
Gut microbiota — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) 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 — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) 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 — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Insulin — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) Changes in insulin levels (μU/mL) levels from baseline.
Total cholesterol — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) Changes in total cholesterol levels (mg/dL) from baseline.
LDL cholesterol — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline.
Triacylglycerides — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) Changes in triacylglycerides (mg/dL) levels from baseline.
Exhaled breath gas profile — At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) Changes in exhaled methane and hydrogen represented in parts per million (ppm) from baseline.
Trial sites (1)
Facility
City
Region
Status
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon
Portugal
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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