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

May 24, 2018 updated by: Thomas Meinert Larsen, University of Copenhagen

Effects of a Combination of Prebiotic Fibres on Weight Loss During an Energy Restricted Diet in an Overweight/Obese Population

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prebiotics are nutrients that specifically utilized by the gut microbiota. Beneficial health effects of prebiotics are generally attributed to 1) stimulation of beneficial bacteria and SCFA production, and consequently; improved barrier function, regulation of enteroendocrine peptide secretion and resistance to inflammatory stimuli; 2) modulation of lipid metabolism, possibly by suppression of lipogenic enzymes and thus decreased synthesis of lipoproteins and triglycerides; and 3) increased mineral absorption.

Inulin is recognized as a common prebiotic. Fibersol-2 is a resistant starch that has been suggested to induce satiety, when given in a dose of 10 g. Intake of inulin has been shown to induce changes in the microbial abundance and increase production of SCFA19; whereas resistant starch has been shown to improve insulin sensitivity and postprandial glucose AUC20. However, the effects of an intervention with a combination of these two fibers on obesity and body composition during an energy restricted diet have not been addressed. Supplements with other types of fibres in addition to energy restriction have shown additional effects in weight reduction.

In this study, the effects of a combination product of two prebiotic fibres on additional weight loss during energy restriction in a placebo-controlled, randomized parallel study with a duration of 12 weeks will be tested. Furthermore, the effects of the fibres on the gut microbial composition, markers of metabolic syndrome (MetS) and glucose metabolism will be tested. The active diet will contain intervention products high in dietary fibre and the placebo diet will contain maltodextrin. The fiber-containing dietary supplements will add approximately 20 g of prebiotic fibres per day, where approximately 10 g will be inulin and approximately 10 g will be resistant maltodextrin. The intervention products and placebo will be consumed as milk. The fiber-containing dietary supplement is expected to induce additional weight loss, compared to placebo and to affect the gut microbiome and markers of metabolic disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg C
      • Frederiksberg, Frederiksberg C, Denmark, 1958
        • Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fiber-containing dietary supplement
2 x 200 ml of fiber-enriched UHT milk during 12 weeks of energy restriction
Dietary supplement: Fiber-containing dietary supplement
Effects of fiber-containing dietary supplement on weight loss during energy restriction
Placebo Comparator: Placebo
2 x 200 ml of UHT milk with maltodextrin during 12 weeks of energy restriction
Dietary supplement: Placebo
Effects of placebo supplement on weight loss during energy restriction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Changes in body composition
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
Changes in gut microbiota composition and function (faecal samples) assesed by metagenomics
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
Glucose and insulin homeostasis
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
Analyses of lipids in blood samples
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
Changes in concentration of inflammatory markers
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
Changes in faecal concentration of short chain fatty acids
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
Changes in concentration of lipids and bile acids in blood and faecal samples
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
Analyses of metabolites in blood, urine and fecal samples
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
Interaction between differences in changes in body weight between the group that receives fiber-containing dietary supplement and placebo group and each of baseline fasting glucose, baseline fasting insulin and baseline microbiome composition (e.g. enterotype).
Measurements will be performed at baseline and after 12 weeks of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Measurement of physical activity, as assessed by Actigraph monitors
Measurements will be performed at baseline and after 12 weeks of intervention
Appetite regulation
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Markers of appetite regulation
Measurements will be performed at baseline and after 12 weeks of intervention
Gene expression
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Measurements of gene expression in of selected genes
Measurements will be performed at baseline and after 12 weeks of intervention
Epigenetics
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Measurements of epigenetic markers in biological samples
Measurements will be performed at baseline and after 12 weeks of intervention
Blood pressure
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Blood pressure measured by an automated blood pressure monitor
Measurements will be performed at baseline and after 12 weeks of intervention
Liver markers
Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention
Measurement of markers of liver health
Measurements will be performed at baseline and after 12 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Reading
TNO
National Research Council, Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas M Larsen, PhD, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Shared personal data collected includes basic data and demographics as well as health related data (weight, blood pressure, medical history etc.) and biological samples including maximum 50 mL blood, faecal samples and spot urine collected at baseline and during the study. The blood samples collected will be used for the analyses of markers of glucose metabolism, lipid metabo-lism and inflammation. Urine collection will be used for metabolomics analyses. Faecal samples will be used for metagenomics analyses and analysis of bile acids. Biological samples will be stored in the research biobank for 5 years and destroyed afterwards.

Link between participant number and personal identification will be separated and stored in one protected participant number log.

Personal data will be stored for 5 years, where data will be anonymized by destroying basic data sheet and participant number log.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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