The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass

NCT01978691 | Completed Phase 2

• 1 other identifier: SMR-2782
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 4

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.

Conditions

Obesity; Hyperglycemia; Insulin Resistance

Keywords

Obesity; Blood glucose; Waist circumference; Lipid metabolism; Probiotics; Prebiotics; Dietary supplements; Endotoxemia

Outcome Measures

Primary Outcomes (1)

• Difference in body fat mass from baseline to end-of-treatment (6 months)

  Measured with dual-energy x-ray absorptiometry (DXA)

  From baseline to end of intervention (6 months)

Secondary Outcomes (18)

• Change in weight (absolute and relative)

  Months 0, 2, 4, 6 and 7 (follow-up)

• Change in BMI (absolute and relative)

  Months 0, 2, 4, 6 and 7 (follow-up)

• Change in lean body mass

  Months 0, 2, 4, 6 and 7 (follow-up)

• Hip Change in waist and/or hip circumference (absolute and relative)

  Months 0, 2, 4, 6 and 7 (follow-up)

• Change in glycated haemoglobin (HbA1c) in blood

  Months 0, 2, 4, 6 and 7 (follow-up)

Other Outcomes (1)

• The differences between the treatment groups for exploratory variables

  Throughout the 6-month study and 1-month follow-up

Study Arms (4)

Probiotic

ACTIVE COMPARATOR

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

Dietary Supplement: Bifidobacterium animalis ssp. lactis 420

Prebiotic

ACTIVE COMPARATOR

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

Dietary Supplement: Polydextrose

Synbiotic

ACTIVE COMPARATOR

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

Dietary Supplement: Bifidobacterium animalis ssp. lactis 420; Dietary Supplement: Polydextrose

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Bifidobacterium animalis ssp. lactis 420 DIETARY_SUPPLEMENT

Studied as a probiotic bacteria

Also known as: B420

Probiotic; Synbiotic

Polydextrose DIETARY_SUPPLEMENT

Studied as a prebiotic

Also known as: Litesse, Litesse Ultra

Prebiotic; Synbiotic

Placebo OTHER

Control

Also known as: Microcrystalline cellulose

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• \> 50 - \<100 µg/day during the previous 2 weeks
• ≥ 100 - \<150 µg/day during the previous 2 months

Sponsors & Collaborators

• Danisco: lead

Study Sites (4)

VL-Medi

Helsinki, 00101, Finland

Location

Kerava healthcare center

Kerava, 04200, Finland

Location

FinnMedi Oy

Tampere, 33520, Finland

Location

CRST - Clinical Research Services Turku

Turku, 20521, Finland

Location

Related Publications (3)

• 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.

  PMID: 21735552 BACKGROUND

• 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.

  PMID: 30525950 DERIVED

• 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.

  PMID: 27810310 DERIVED

MeSH Terms

Conditions

Obesity; Hyperglycemia; Insulin Resistance; Endotoxemia

Interventions

20-aldehyde leukotriene B4; polydextrose; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Aila Rissanen, MD

  HYKS-instituutti Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

FI (4)