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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Wheat-based fermented beverage (developed under the WHEATBIOME project) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat-based fermented beverage | Other | Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| 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. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Fasting blood glucose | Changes in fasting blood glucose levels (mg/dL) levels from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Insulin | Changes in insulin levels (μU/mL) levels from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Total cholesterol | Changes in total cholesterol levels (mg/dL) from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| LDL cholesterol | Changes in low-density lipoprotein (LDL) cholesterol (mg/dL) levels from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Triacylglycerides |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Changes in weight (kg) from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Body fat mass | Changes in percentage of body fat mass from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Faria | Contact | +351218803000 | ana.faria@nms.unl.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa | Lisbon | Portugal |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2025 | Apr 24, 2026 | ICF_000.pdf |
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Changes in triacylglycerides (mg/dL) levels from baseline.
| At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Exhaled breath gas profile | Changes in exhaled methane and hydrogen represented in parts per million (ppm) from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| 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). | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Interleukin-6 | Changes in interleukin-6 (pg/mL) from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |
| Tumor Necrosis Factor-alpha | Changes in Tumor Necrosis Factor-alpha (pg/mL) from baseline. | At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks) |