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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03135041
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 29, 2018
Sponsor:
Collaborators:
University of Reading
TNO
National Research Council, Spain
Information provided by (Responsible Party):
Thomas Meinert Larsen, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE April 26, 2017
First Posted Date  ICMJE May 1, 2017
Last Update Posted Date May 29, 2018
Actual Study Start Date  ICMJE May 26, 2017
Actual Primary Completion Date May 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
  • Body composition [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Changes in body composition
  • 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
  • Glucose metabolism [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Glucose and insulin homeostasis
  • Lipid metabolism [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Analyses of lipids in blood samples
  • Inflammatory markers [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Changes in concentration of inflammatory markers
  • 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
  • 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
  • Metabolomics [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Analyses of metabolites in blood, urine and fecal samples
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • Body composition [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Changes in body composition
  • 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)
  • Glucose metabolism [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Glucose and insulin homeostasis
  • Lipid metabolism [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Analyses of lipids in blood samples
  • Inflammatory markers [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Changes in concentration of inflammatory markers
  • 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
  • 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
  • Metabolomics [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Analyses of metabolites in blood, urine and fecal samples
  • 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).
Current Other Pre-specified Outcome Measures
 (submitted: April 26, 2017)
  • 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
  • Appetite regulation [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Markers of appetite regulation
  • Gene expression [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Measurements of gene expression in of selected genes
  • Epigenetics [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Measurements of epigenetic markers in biological samples
  • 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
  • Liver markers [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Measurement of markers of liver health
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Prebiotic Fibres on Weight Loss in an Overweight and Obese Population
Official Title  ICMJE Effects of a Combination of Prebiotic Fibres on Weight Loss During an Energy Restricted Diet in an Overweight/Obese Population
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Fiber-containing dietary supplement
    2 x 200 ml of fiber-enriched UHT milk during 12 weeks of energy restriction
    Intervention: Dietary Supplement: Fiber-containing dietary supplement
  • Placebo Comparator: Placebo
    2 x 200 ml of UHT milk with maltodextrin during 12 weeks of energy restriction
    Intervention: Dietary Supplement: Placebo
Publications * Hess AL, Benítez-Páez A, Blædel 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. 2019 Oct 11. doi: 10.1007/s00394-019-02099-x. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2018)
117
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
120
Actual Study Completion Date  ICMJE May 24, 2018
Actual Primary Completion Date May 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03135041
Other Study ID Numbers  ICMJE B328
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Responsible Party Thomas Meinert Larsen, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • University of Reading
  • TNO
  • National Research Council, Spain
Investigators  ICMJE
Principal Investigator: Thomas M Larsen, PhD University of Copenhagen
PRS Account University of Copenhagen
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP