The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass

NCT ID: NCT01978691

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Bifidobacterium animalis ssp. lactis 420 (10\^10 colony-forming units (CFU)/day in 12 g of microcrystalline cellulose), once per day for six months in a sachet mixed into a smoothie drink

Group Type: ACTIVE_COMPARATOR

Bifidobacterium animalis ssp. lactis 420

Intervention Type: DIETARY_SUPPLEMENT

Studied as a probiotic bacteria

Prebiotic

Polydextrose, 12 g once per day for six months in a sachet mixed into a smoothie drink

Group Type: ACTIVE_COMPARATOR

Polydextrose

Intervention Type: DIETARY_SUPPLEMENT

Studied as a prebiotic

Synbiotic

B. lactis 420 (10\^10 CFU/day) in 12 g of polydextrose, once per day for six months in a sachet to be mixed into a smoothie drink

Group Type: ACTIVE_COMPARATOR

Bifidobacterium animalis ssp. lactis 420

Intervention Type: DIETARY_SUPPLEMENT

Studied as a probiotic bacteria

Polydextrose

Intervention Type: DIETARY_SUPPLEMENT

Studied as a prebiotic

Control

12 g of microcrystalline cellulose once per day for six months in a sachet to be mixed into a smoothie drink

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Control

Interventions

Bifidobacterium animalis ssp. lactis 420

Studied as a probiotic bacteria

Intervention Type: DIETARY_SUPPLEMENT

Polydextrose

Studied as a prebiotic

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Control

Intervention Type: OTHER

Other Intervention Names

B420; Litesse; Litesse Ultra; Microcrystalline cellulose

Eligibility Criteria

Inclusion Criteria

• BMI between 28.0-34.9
• Waist to hip ratio: males ≥0.88, females ≥0.83
• Age 18-65 years
• Signed informed consent
• Available for all study visits and phone calls
• Follows a regular diet that is in agreement with the national dietary recommendations

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:

1. > 50 - <100 µg/day during the previous 2 weeks

2. ≥ 100 - <150 µg/day during the previous 2 months

3. ≥150 µg/day or above during the previous 12 months

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danisco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aila Rissanen, MD

Role: PRINCIPAL_INVESTIGATOR

HYKS-instituutti Oy

Locations

VL-Medi

Helsinki, , Finland

Kerava healthcare center

Kerava, , Finland

FinnMedi Oy

Tampere, , Finland

CRST - Clinical Research Services Turku

Turku, , Finland

Countries

Finland

References

Amar J, Chabo C, Waget A, Klopp P, Vachoux C, Bermudez-Humaran LG, Smirnova N, Berge M, Sulpice T, Lahtinen S, Ouwehand A, Langella P, Rautonen N, Sansonetti PJ, Burcelin R. Intestinal mucosal adherence and translocation of commensal bacteria at the early onset of type 2 diabetes: molecular mechanisms and probiotic treatment. EMBO Mol Med. 2011 Sep;3(9):559-72. doi: 10.1002/emmm.201100159. Epub 2011 Aug 3.

Reference Type: BACKGROUND

PMID: 21735552 (View on PubMed)

Hibberd AA, Yde CC, Ziegler ML, Honore AH, Saarinen MT, Lahtinen S, Stahl B, Jensen HM, Stenman LK. Probiotic or synbiotic alters the gut microbiota and metabolism in a randomised controlled trial of weight management in overweight adults. Benef Microbes. 2019 Mar 13;10(2):121-135. doi: 10.3920/BM2018.0028. Epub 2018 Dec 10.

Reference Type: DERIVED

PMID: 30525950 (View on PubMed)

Stenman LK, Lehtinen MJ, Meland N, Christensen JE, Yeung N, Saarinen MT, Courtney M, Burcelin R, Lahdeaho ML, Linros J, Apter D, Scheinin M, Kloster Smerud H, Rissanen A, Lahtinen S. Probiotic With or Without Fiber Controls Body Fat Mass, Associated With Serum Zonulin, in Overweight and Obese Adults-Randomized Controlled Trial. EBioMedicine. 2016 Nov;13:190-200. doi: 10.1016/j.ebiom.2016.10.036. Epub 2016 Oct 26.

Reference Type: DERIVED

PMID: 27810310 (View on PubMed)

Other Identifiers

SMR-2782

Identifier Type: -

Identifier Source: org_study_id