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

NCT03135041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2018-05-29

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Fiber-containing dietary supplement

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

DIETARY_SUPPLEMENT

Placebo

Effects of placebo supplement on weight loss during energy restriction

Sponsors & Collaborators

  • University of Reading

    collaborator OTHER

  • TNO

    collaborator OTHER

  • National Research Council, Spain

    collaborator OTHER_GOV

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Thomas M Larsen, PhD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-26
Primary Completion
2018-05-24
Completion
2018-05-24

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03135041 on ClinicalTrials.gov