Actively Recruiting

Phase Not Applicable
Age: 25Years +
All Genders
NCT07036692

The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention

Led by University of Bern · Updated on 2025-11-21

120

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

Sponsors

U

University of Bern

Lead Sponsor

D

DCB Research AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

The main aim of this study is to assess the effect of a chewing gum containing galactooligosaccharides (GOS) on the body mass index (BMI), the metabolism and the oral and intestinal microbiomes in a population of overweight adults.

CONDITIONS

Official Title

The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention

Who Can Participate

Age: 25Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent according to ICH/GCP regulations before any study procedures
  • Adults aged 25 years or older
  • Overweight with a Body Mass Index greater than 25 kg/m2
  • At least one metabolic risk factor: HbA1c 5.7% or higher, elevated liver enzymes (ALAT, ASAT, or gGT above normal range), LDL cholesterol above 3.0 mmol/l, or triglycerides above 1.7 mmol/l
  • Ability and willingness to follow the study protocol including gum chewing and fecal sample collection
  • Access to a scale for self-reporting weight
  • Access to and willingness to use an electronic device like a mobile phone, computer, or tablet
  • Recent laboratory blood assessments performed within a reasonable timeframe before eligibility assessment as determined by the principal investigator
Not Eligible

You will not qualify if you...

  • Use of systemic antibiotics within the last 2 months
  • History of bariatric surgery
  • Started or changed dosage of medication for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)
  • Use of prebiotic or probiotic supplements for more than 1 month within the last 6 weeks
  • Weight management medications (e.g., GLP-1 agonists) used within the last year
  • Proton pump inhibitor use started, stopped, or changed dose within the last month
  • Professionally supervised intensive weight management treatments ongoing for more than 6 months within the last year
  • Diagnosed Type 1 or Type 2 diabetes requiring bolus insulin or frequent insulin dose changes
  • Regular alcohol use exceeding two standard drinks per day for women or three for men
  • Use of more than one nicotine product per month
  • Regular drug abuse at least once per week over the past 4 months
  • Current pregnancy or lactation
  • Active cancer or cancer treatment within the last 4 months
  • Chronic active inflammatory diseases like inflammatory bowel disease or rheumatoid arthritis
  • Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, or gastroparesis
  • Medically diagnosed eating disorder
  • Participation in another investigational drug study within 30 days before randomization
  • Dependency on the sponsor-investigator
  • Last visit with the treatment provider more than 22 days before eligibility assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Biomedical Research, University of Bern

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

M

Maria L Balmer, Prof. med.

CONTACT

J

Janina N Zünd, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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