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

NCT07560527 | Not Yet Recruiting

• 1 other identifier: WHEATBIOME
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Adult Subjects

Outcome Measures

Primary Outcomes (8)

• 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

  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)

Secondary Outcomes (5)

• Weight

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

• Body fat mass

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

• Gastrointestinal quality of life

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

• Interleukin-6

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

• Tumor Necrosis Factor-alpha

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

Study Arms (1)

Intervention

EXPERIMENTAL

Wheat-based fermented beverage (developed under the WHEATBIOME project)

Other: Wheat-based fermented beverage

Interventions

Wheat-based fermented beverage OTHER

Daily consumption of one serving of a wheat-based fermented beverage (developed under the WHEATBIOME project) for 4 weeks.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead

Study Sites (1)

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Lisbon, Portugal

Location

Central Study Contacts

Ana Faria

CONTACT

+351218803000; ana.faria@nms.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)