NCT01978691

The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass

The Effect of Separate or Combined Supplementation of Probiotic (Bifidobacterium Lactis B420) and Polydextrose on Body Fat Mass

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Hyperglycemia
• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium animalis ssp. lactis 420	Studied as a probiotic bacteria
DIETARY_SUPPLEMENT	Polydextrose	Studied as a prebiotic
OTHER	Placebo	Control

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-11-07
• Last updated: 2016-02-02

Locations

4 sites across 1 country: Finland