The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass
Condition: Obesity; Hyperglycemia; Insulin Resistance
MeSH terms: Insulin Resistance; Hyperglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid
      metabolism. The purpose of this study is to investigate the effect of a dietary supplement
      containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on
      change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial.
      The supplement is ingested once per day for the duration of six months, and participants will
      attend a follow-up visit one month after the end of the intervention. The study will enroll
      232 participants (58 per study arm) in four research centers in southern Finland.
    

Detailed description: 
      Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid
      metabolism. Preclinical studies have shown that weight gain and insulin resistance may be
      prevented by oral administration of the probiotic Bifidobacterium animalis ssp. lactis 420.
      Furthermore, the prebiotic polydextrose has shown efficacy on satiety in clinical settings.
      The purpose of this study is to investigate the effects of these products, individually and
      combined, on change in body fat mass in a double-blind, randomized, placebo-controlled
      intervention trial. The study is conducted at four research clinics in southern Finland. The
      supplement is provided in a sachet, mixed into a fruit smoothie and ingested once per day for
      the duration of six months. One month from the end of the intervention participants will
      attend a follow-up visit. The study will enroll 232 participants, who will be randomized into
      blocks using a computerized procedure.

      After the screening visit, there will be seven study visits (once per month) and one
      follow-up visit. Visits at months 0, 2, 4, 6 and follow-up are clinic visits, and visits at
      months 1, 3 and 5 are phone contacts to check compliance and any adverse events.

      Clinic visits include the following measurements and samples:

        -  weight

        -  blood pressure and heart rate

        -  blood samples

        -  returning of food diaries (only during intervention)

        -  returning of exercise questionnaires and food choice questionnaires (only beginning and
           end of treatment)

        -  returning of fecal samples, taken at home by participant

        -  DXA for body composition analysis

        -  hip and waist circumference

        -  brief physical examination (only beginning and end of treatment)

        -  recording of adverse events and concomitant medication

      For compliance check, unused sachets are returned to the clinic and counted. At the follow-up
      visit participants will receive guidance on exercise and a healthy diet.

      The primary variable of this study is relative change from baseline to end-of-treatment in
      body fat mass. Comparisons between each of the active groups against the placebo group will
      be performed if the global P-value is significant. Secondary variables will be analyzed in a
      similar fashion. The relative and absolute changes in body fat mass will also be analyzed. To
      explore the mechanism of potential treatment benefits, post-hoc responder analyses may
      optionally be performed. Also, correlations between the response variables may be examined in
      exploratory analyses. Post-hoc analyses may be conducted to compare e.g. different time
      points or to analyze differences from end-of-treatment to follow-up.
    

Intervention name(s): Bifidobacterium animalis ssp. lactis 420; Polydextrose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Studied as a probiotic bacteria; Studied as a prebiotic; Control
Other intervention name(s): B420; Litesse; Litesse Ultra; Microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Obesity; Blood glucose; Waist circumference; Lipid metabolism; Probiotics; Prebiotics; Dietary supplements; Endotoxemia