Not Yet RecruitingNot Applicable

Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals

Portugal20 participantsStarted 2026-05-20

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gut microbiota

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Oral microbiota

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Fasting blood glucose

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Insulin

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Total cholesterol

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

LDL cholesterol

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Triacylglycerides

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Trial details

NCT IDNCT07560527

SponsorUniversidade Nova de Lisboa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Ana Faria

+351218803000 ana.faria@nms.unl.pt

View on ClinicalTrials.gov More Health Adult Subjects trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Gut microbiota

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Oral microbiota

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Fasting blood glucose

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Insulin

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Total cholesterol

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

LDL cholesterol

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)

Triacylglycerides

Timeframe: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)