Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidade Nova de Lisboa
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Gut microbiota
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention
Wheat-based fermented beverage (developed under the WHEATBIOME project)
Intervention: Wheat-based fermented beverage (Other)
Outcomes
Primary Outcomes
Gut microbiota
Time Frame: 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
Time Frame: 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
Time Frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Insulin
Time Frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in insulin levels (μU/mL) levels from baseline.
Total cholesterol
Time Frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in total cholesterol levels (mg/dL) from baseline.
LDL cholesterol
Time Frame: 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
Time Frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in triacylglycerides (mg/dL) levels from baseline.
Exhaled breath gas profile
Time Frame: 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.
Secondary Outcomes
- Weight(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Body fat mass(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Gastrointestinal quality of life(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Interleukin-6(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))
- Tumor Necrosis Factor-alpha(At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks))