The Effect of Prebiotic Fibres on Weight Loss in an Overweight and Obese Population
Condition: Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

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.
    

Intervention name(s): Fiber-containing dietary supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Effects of fiber-containing dietary supplement on weight loss during energy restriction; Effects of placebo supplement on weight loss during energy restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prebiotics; Microbiome; Glucose metabolism