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

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 Overview

• Status: Not yet recruiting
• Conditions: Health Adult Subjects
• Intervention / Treatment: Other: Wheat-based fermented beverage

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Faria; Phone Number: +351218803000; Email: ana.faria@nms.unl.pt

Study Locations

• Portugal
  • Lisbon, Portugal
    • NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
    • Contact: Ana Faria; Phone Number: +351218803000; Email: ana.faria@nms.unl.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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 Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: WHEATBIOME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No