The Effect of Prebiotic Fibres on Weight Loss in an Overweight and Obese Population

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03135041
• Date of registration: 26/04/2017
• Prospective Registration: Yes
• Primary sponsor: University of Copenhagen
• Public title: The Effect of Prebiotic Fibres on Weight Loss in an Overweight and Obese Population MNGII
• Scientific title: Effects of a Combination of Prebiotic Fibres on Weight Loss During an Energy Restricted Diet in an Overweight/Obese Population
• Date of first enrolment: May 26, 2017
• Target sample size: 117
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03135041
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Thomas M Larsen, PhD
• Affiliation: University of Copenhagen

Key inclusion & exclusion criteria

Inclusion Criteria:

- BMI: 28-45 kg/m2

- Non-smoking

- Haemoglobin level =7 mmol/L

Exclusion Criteria:

- Use of antibiotics three months prior to study and during the study. If a participant
uses antibiotics prior to randomization, the participant will be invited to be
re-screened 3 months after the last use of antibiotics, provided that it is realistic
to complete the study no later than the scheduled LPLV

- Weight change >3 kg two months prior to study

- Blood donation other than for this study <1 month prior to study and during study.

- Participation in clinical trials other than for this <1 month prior to study and
during study

- Intensive physical training/ elite athlete (>10 hours of strenuous physical activity
per week)

- Unstable medication for dyslipidaemia and elevated blood pressure (the participant
must have had a stable dose in the three months prior to study start), and use of
systemic glucocorticoids

- Medication for T2D

- Treatment with metformin

- Dietary supplements with pro- and/or prebiotics and/or fibre 6 weeks prior to study

- Special dietary regimen (vegetarians, vegans etc.), as evaluated by study staff

- Lactose intolerance or allergy to components in the intervention products

- Gluten intolerance

- Maltodextrin intolerance

- Lactation, pregnancy or planning of pregnancy during the study

- Gastro intestinal and liver disorders

- Chronic inflammation disorders (excluding obesity)

- Diagnosed psychiatric disorder including depression requiring treatment

- Surgical treatment of obesity and abdominal surgery

- Inability, physically or mentally, to comply with the procedures required by the study
protocol, as evaluated by the study staff



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Fiber-containing dietary supplement

Primary Outcome(s)

Weight loss [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Secondary Outcome(s)

Body composition [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Glucose metabolism [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Gut microbiota composition and function [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Inflammatory markers [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Lipid metabolism [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Metabolomics [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Lipidomics and bile acids [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Weight loss [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

SCFA concentration [Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention]

Secondary ID(s)

B328

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Research Council, Spain

TNO

University of Reading