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

Obesity Clinical Trial

— MNGII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135041
• Other study ID #: B328
• Status: Completed
• Phase: N/A
• Start date: May 26, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: May 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 24, 2018
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Dietary Supplement:
• Fiber-containing dietary supplement
Effects of fiber-containing dietary supplement on weight loss during energy restriction
• Placebo
Effects of placebo supplement on weight loss during energy restriction

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Frederiksberg	Frederiksberg C

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	National Research Council, Spain, TNO, University of Reading

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	Measurement of physical activity, as assessed by Actigraph monitors	Measurements will be performed at baseline and after 12 weeks of intervention
Other	Appetite regulation	Markers of appetite regulation	Measurements will be performed at baseline and after 12 weeks of intervention
Other	Gene expression	Measurements of gene expression in of selected genes	Measurements will be performed at baseline and after 12 weeks of intervention
Other	Epigenetics	Measurements of epigenetic markers in biological samples	Measurements will be performed at baseline and after 12 weeks of intervention
Other	Blood pressure	Blood pressure measured by an automated blood pressure monitor	Measurements will be performed at baseline and after 12 weeks of intervention
Other	Liver markers	Measurement of markers of liver health	Measurements will be performed at baseline and after 12 weeks of intervention
Primary	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	Body composition	Changes in body composition	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	Gut microbiota composition and function	Changes in gut microbiota composition and function (faecal samples) assesed by metagenomics	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	Glucose metabolism	Glucose and insulin homeostasis	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	Lipid metabolism	Analyses of lipids in blood samples	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	Inflammatory markers	Changes in concentration of inflammatory markers	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	SCFA concentration	Changes in faecal concentration of short chain fatty acids	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	Lipidomics and bile acids	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
Secondary	Metabolomics	Analyses of metabolites in blood, urine and fecal samples	Measurements will be performed at baseline and after 12 weeks of intervention
Secondary	Weight loss	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