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

NCT03135041 | Completed DMC

• 1 other identifier: B328
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate whether a diet supplemented with two prebiotic fibres induces greater changes in body weight compared to placebo during 12 weeks of energy restriction in an obese/overweight population. The hypothesis is that the fiber-containing dietary supplement will: 1\) Induce greater changes in body weight compared to the placebo group 2) change the gut microbiota composition 3) improve glucose homeostasis 4) decrease serum concentration of triglycerides, total and LDL cholesterol The hypothesis is that the effect of the intervention on weight loss will be partly mediated by the diet-induced changes in the gut microbiota composition.

Conditions

Obesity

Keywords

Prebiotics; Microbiome; Glucose metabolism

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Differences in changes in body weight between the group that receives fiber-containing dietary supplement and placebo group

  Measurements will be performed at baseline and after 12 weeks of intervention

Secondary Outcomes (9)

• Body composition

  Measurements will be performed at baseline and after 12 weeks of intervention

• Gut microbiota composition and function

  Measurements will be performed at baseline and after 12 weeks of intervention

• Glucose metabolism

  Measurements will be performed at baseline and after 12 weeks of intervention

• Lipid metabolism

  Measurements will be performed at baseline and after 12 weeks of intervention

• Inflammatory markers

  Measurements will be performed at baseline and after 12 weeks of intervention

Other Outcomes (6)

• Physical activity

  Measurements will be performed at baseline and after 12 weeks of intervention

• Appetite regulation

  Measurements will be performed at baseline and after 12 weeks of intervention

• Gene expression

  Measurements will be performed at baseline and after 12 weeks of intervention

Study Arms (2)

Fiber-containing dietary supplement

EXPERIMENTAL

2 x 200 ml of fiber-enriched UHT milk during 12 weeks of energy restriction

Dietary Supplement: Fiber-containing dietary supplement

Placebo

PLACEBO COMPARATOR

2 x 200 ml of UHT milk with maltodextrin during 12 weeks of energy restriction

Dietary Supplement: Placebo

Interventions

Fiber-containing dietary supplement DIETARY_SUPPLEMENT

Effects of fiber-containing dietary supplement on weight loss during energy restriction

Fiber-containing dietary supplement

Placebo DIETARY_SUPPLEMENT

Effects of placebo supplement on weight loss during energy restriction

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI: 28-45 kg/m2
• Non-smoking
• Haemoglobin level ≥7 mmol/L

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Reading: collaborator
• TNO: collaborator
• National Research Council, Spain: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports

Frederiksberg, Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

• Hess AL, Benitez-Paez A, Blaedel T, Larsen LH, Iglesias JR, Madera C, Sanz Y, Larsen TM; MyNewGut Consortium. The effect of inulin and resistant maltodextrin on weight loss during energy restriction: a randomised, placebo-controlled, double-blinded intervention. Eur J Nutr. 2020 Sep;59(6):2507-2524. doi: 10.1007/s00394-019-02099-x. Epub 2019 Oct 11.

  PMID: 31605197 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas M Larsen, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: May 26, 2017
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)