Health Adult SubjectsNCT07560527
Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
A study testing Wheat-based fermented beverage in people with Health Adult Subjects, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- Wheat-based fermented beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 20 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon
Ana Faria, +351218803000, ana.faria@nms.unl.pt
About this study
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.
- Conditions
- Health Adult Subjects
- Being tested
- Wheat-based fermented beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat-based fermented beverageOther
Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Wheat-based fermented beverage (developed under the WHEATBIOME project) Receives: Other: Wheat-based fermented beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Insulin
Changes in insulin levels (μU/mL) levels from baseline.
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Total cholesterol
Changes in total cholesterol levels (mg/dL) from baseline.
Measured: 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.
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Triacylglycerides
Changes in triacylglycerides (mg/dL) levels from baseline.
Measured: 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.
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Secondary outcomes (5)
Weight
Changes in weight (kg) from baseline.
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Body fat mass
Changes in percentage of body fat mass from baseline.
Measured: 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).
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Interleukin-6
Changes in interleukin-6 (pg/mL) from baseline.
Measured: 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.
Measured: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start20 May 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560527
- Sponsor's protocol ID
- WHEATBIOME
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Wheat-based Fermented Beverage on Microbiota and Metabolic Health in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07560527
- Acronym / sponsor ID
- WHEATBIOME
- Conditions
- Health Adult Subjects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Wheat-based fermented beverageWheat-based fermented beverage (developed under the WHEATBIOME project) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat-based fermented beverageDaily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks. | Other | Intervention |
Primary outcome
Gut microbiota
Time frame: 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
Time frame: 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
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in fasting blood glucose levels (mg/dL) levels from baseline.
Insulin
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in insulin levels (μU/mL) levels from baseline.
Total cholesterol
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in total cholesterol levels (mg/dL) from baseline.
LDL cholesterol
Time frame: 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
Time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)
Changes in triacylglycerides (mg/dL) levels from baseline.
Exhaled breath gas profile
Time frame: 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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat-based fermented beverage in people with Health Adult Subjects, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Faria (+351218803000, ana.faria@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: At visit 1 (Baseline) and visit 2 (end of intervention - 4 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.