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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
117
Effects of fiber-containing dietary supplement on weight loss during energy restriction
Effects of placebo supplement on weight loss during energy restriction
Department of Nutrition, Exercise and Sports
Frederiksberg, Frederiksberg C, Denmark
Weight loss
Differences in changes in body weight between the group that receives fiber-containing dietary supplement and placebo group
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Body composition
Changes in body composition
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Gut microbiota composition and function
Changes in gut microbiota composition and function (faecal samples) assesed by metagenomics
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Glucose metabolism
Glucose and insulin homeostasis
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Lipid metabolism
Analyses of lipids in blood samples
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Inflammatory markers
Changes in concentration of inflammatory markers
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
SCFA concentration
Changes in faecal concentration of short chain fatty acids
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Lipidomics and bile acids
Changes in concentration of lipids and bile acids in blood and faecal samples
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
Metabolomics
Analyses of metabolites in blood, urine and fecal samples
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
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).
Time frame: Measurements will be performed at baseline and after 12 weeks of intervention
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