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NCT Number: NCT07560527

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.

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Key information

Conditions

Health Adult Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lisbon, Portugal

Location contact

Ana Faria

CONTACT

[email protected]

+351218803000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheat-based fermented beverage

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Insulin

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

    Changes in insulin levels (μU/mL) levels from baseline.

  5. 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.

  6. 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.

  7. Triacylglycerides

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

    Changes in triacylglycerides (mg/dL) levels from baseline.

  8. 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.

Secondary outcomes

  1. Weight

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

    Changes in weight (kg) from baseline.

  2. Body fat mass

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

    Changes in percentage of body fat mass from baseline.

  3. Gastrointestinal quality of life

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

    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).

  4. Interleukin-6

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

    Changes in interleukin-6 (pg/mL) from baseline.

  5. Tumor Necrosis Factor-alpha

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

    Changes in Tumor Necrosis Factor-alpha (pg/mL) from baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Faria

CONTACT

[email protected]

+351218803000

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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