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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.
Full 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:
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.
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Inclusion criteria
Exclusion criteria
Diagnosed type 1 or type 2 diabetes (i.e. fasting plasma glucose ≥ 7 mmol/l and HbA1C ≥ 6.5%)
Use of medication for diabetes, dyslipidemia or hypertension
Use of laxatives or fiber supplements in the past 6 weeks
History of diagnosed coronary heart disease, other significant cardiovascular disease or artificial heart valve
History of chronic active inflammatory disorders
History of bariatric surgery
Use of anti-obesity drugs in the last 3 months
Use of anticoagulants
Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs
Recent (last 2 months) or ongoing antibiotic use
Immunosuppression or ongoing therapy causing immunosuppression
Use of probiotics more than once a week during the previous 6 weeks
Use of vitamin D supplementation:
Active or recent (last 3 months) participation in a weight loss program or weight change (increase or loss) of 3 kg during the past 3 months
Pregnant or planning pregnancy within 6 months or breastfeeding women
Participation in a clinical trial with an investigational product or drug within 60 days prior to screening
Likeliness to be noncompliant with the protocol
Drug or alcohol abuse
Allergy to any of the ingredients used in the study
Other reasons that, in the opinion of the Investigator makes the subject unsuitable for enrolment
Primary purpose
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Interventional model
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225 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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