An interventional study of Wheat-based fermented beverage in Health Adult Subjects, sponsored by Universidade Nova de Lisboa. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Universidade Nova de Lisboa · Not applicable, Interventional, and Other
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.
Universidade Nova de Lisboa is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Wheat-based fermented beverage (developed under the WHEATBIOME project)
Other: Wheat-based fermented beverage
Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Insulin
Changes in insulin levels (μU/mL) levels from baseline.
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Total cholesterol
Changes in total cholesterol levels (mg/dL) from baseline.
Time frame: 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.
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Triacylglycerides
Changes in triacylglycerides (mg/dL) levels from baseline.
Time frame: 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.
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Weight
Changes in weight (kg) from baseline.
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Body fat mass
Changes in percentage of body fat mass from baseline.
Time frame: 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).
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Interleukin-6
Changes in interleukin-6 (pg/mL) from baseline.
Time frame: 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.
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Universidade Nova de Lisboa