Health TrialsbyHealthPanel

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

ConditionsNutritional and Metabolic DiseasesOverweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures

Adults aged ≥ 25 years

Overweight as determined by a Body Mass Index > 25 kg/m2

Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)

Disqualifiers

Systemic antibiotic use within the last 2 months

History of bariatric surgery

Initiation or dose adjustment of pharmaceutical treatment for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)

Use of prebiotic or probiotic supplementation (duration >1 month) within the last 6 weeks (at PI's discretion, based on medication summary of TP)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Dietary supplement

    To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.

  • FibreGum

    Dietary supplement

    To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: InterventionalExperimental treatment 1 intervention
Group C: No-treatment controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in the Body Mass Index (BMI) during intervention

Difference in the BMI measured at intervention start and intervention completion

Time frame
4 months

Secondary outcomes

1

Systolic blood pressures change during intervention

Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start.

Time frame
4 months
2

Diastolic blood pressures changes during intervention

Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start.

Time frame
4 months
3

Self-reported weight changes during intervention

Difference in self-reported weight (kg) between intervention completion and intervention start.

Time frame
4 months
4

Self-reported weight changes during follow-up

Difference in self-reported weight (kg) between end of follow-up period and intervention completion.

Time frame
2 months from intervention completion (month 4) to end of follow-up period (month 6)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bern

Lead sponsor

DCB Research AG

Collaborator

Source ClinicalTrials.gov
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