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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in the Body Mass Index (BMI) during intervention [Срок оценки: 4 months]

Вторичные конечные точки (12)

• Systolic blood pressures change during intervention [Срок оценки: 4 months]
• Diastolic blood pressures changes during intervention [Срок оценки: 4 months]
• Self-reported weight changes during intervention [Срок оценки: 4 months]
• Self-reported weight changes during follow-up [Срок оценки: 2 months from intervention completion (month 4) to end of follow-up period (month 6)]
• Waist circumference changes during intervention [Срок оценки: 4 months]
• Waist circumference changes during follow-up [Срок оценки: 2 months from intervention completion (month 4) to end of follow-up period (month 6)]
• Fasting blood glucose change during intervention [Срок оценки: 4 months]
• Fasting insulin change during intervention [Срок оценки: 4 months]
• HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change during intervention [Срок оценки: 4 months]
• Hemoglobin A1c (HbA1c) change during intervention [Срок оценки: 4 months]
• Cholesterol change during intervention [Срок оценки: 4 months]
• Triglyceride change during intervention [Срок оценки: 4 months]

Критерии участия

Критерии включения

• 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
• Metabolic risk factor: at least one of the following criteria:

i. HbA1c ≥ 5.7% ii. Elevated liver enzymes (ALAT, ASAT, Gamma-Glutamyltransferase (gGT) at least one above normal range of the assay used in the respective laboratory) iii. LDL-cholesterol > 3.0 mmol/l iv. Triglycerides > 1.7 mmol/l

• Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
• Access to a scale to self-report weight
• Access and willing to use an electronic device (e.g., mobile phone, computer or tablet)
• Laboratory assessments of blood parameters were performed within a reasonable timeframe prior to the eligibility assessment, as determined by the PI.

Критерии исключения

• 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)
• Medical weight management treatments within the last year (e.g., Glucagon-Like Peptide-1 (GLP-1) agonists)
• Recent (<1 month) dose adjustment, initiation or termination of proton pump inhibitors use (e.g., pantoprazole, omeprazole)
• Professionally supervised intensive (>6 months of ongoing supervision) weight management treatments (e.g., structured nutrition counselling) within the last year (at the PI's discretion)
• Diagnosis of Type 1 or Type 2 diabetes requiring bolus insulin therapy or frequent dose adjustments in base line insulin
• Regular alcohol consumption exceeding two (women) or three (men) standard units (10 g of pure alcohol) per day
• Consumption of more than one nicotine product (e.g., (e-)cigarette, gum) per month
• Regular drug abuse (once per week over the past 4 months)
• Any stage of known pregnancy or lactation period (self-reported)
• Active cancer or recent cancer treatment (within the last 4 months)
• Chronic, active inflammatory diseases (e.g., inflammatory bowel disease, rheumatoid arthritis)
• Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, gastroparesis)
• Known eating disorder (medically diagnosed)
• Participation in another investigation with an investigational drug within the 30 days preceding randomisation
• Dependency from the Sponsor-Investigator
• Last visit with TP > 22 days prior to eligibility assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Department of Biomedical Research, University of Bern — Bern

Идентификаторы

NCT: NCT07036692 · FaibaGo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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