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

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ClinicalTrials.gov Identifier: NCT03135041
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
University of Reading
TNO
National Research Council, Spain
Information provided by (Responsible Party):
Thomas Meinert Larsen, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Fiber-containing dietary supplement Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Combination of Prebiotic Fibres on Weight Loss During an Energy Restricted Diet in an Overweight/Obese Population
Actual Study Start Date : May 26, 2017
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Body composition [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Changes in body composition

  2. 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

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

  4. Lipid metabolism [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Analyses of lipids in blood samples

  5. Inflammatory markers [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Changes in concentration of inflammatory markers

  6. 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

  7. 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

  8. Metabolomics [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Analyses of metabolites in blood, urine and fecal samples

  9. 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).


Other Outcome Measures:
  1. 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

  2. Appetite regulation [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Markers of appetite regulation

  3. Gene expression [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Measurements of gene expression in of selected genes

  4. Epigenetics [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Measurements of epigenetic markers in biological samples

  5. 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

  6. Liver markers [ Time Frame: Measurements will be performed at baseline and after 12 weeks of intervention ]
    Measurement of markers of liver health



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135041


Locations
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Denmark
Department of Nutrition, Exercise and Sports
Frederiksberg, Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
University of Reading
TNO
National Research Council, Spain
Investigators
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Principal Investigator: Thomas M Larsen, PhD University of Copenhagen

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Responsible Party: Thomas Meinert Larsen, Associate Professor, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03135041     History of Changes
Other Study ID Numbers: B328
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Meinert Larsen, University of Copenhagen:
Prebiotics
Microbiome
Glucose metabolism

Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes