Health Adult Subjects
Conditions
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.
Interventions
OTHERWheat-based fermented beverage
Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
Sponsors
Universidade Nova de Lisboa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) | Changes in weight (kg) from baseline. |
| Body fat mass | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) | Changes in percentage of body fat mass from baseline. |
| Gastrointestinal quality of life | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) | 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 | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) | Changes in interleukin-6 (pg/mL) from baseline. |
| Tumor Necrosis Factor-alpha | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) | Changes in Tumor Necrosis Factor-alpha (pg/mL) from baseline. |
Countries
Portugal
Contacts
CONTACTAna Faria
Outcome results
None listed