Not yet recruiting NCT07560527
Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wheat-based fermented beverage.
- Who it may be relevant to
- Registry conditions: Health Adult Subjects. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Wheat-based fermented beverage
Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
Primary outcome measures
- Gut microbiota [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Oral microbiota [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Fasting blood glucose [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Insulin [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Total cholesterol [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- LDL cholesterol [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Triacylglycerides [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Exhaled breath gas profile [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
Secondary outcome measures (5)
- Weight [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Body fat mass [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Gastrointestinal quality of life [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Interleukin-6 [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
- Tumor Necrosis Factor-alpha [Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Portugal · 1 center
- NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa — Lisbon
Identifiers
NCT: NCT07560527 · WHEATBIOME