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The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass (MetSProb)

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ClinicalTrials.gov Identifier: NCT01978691
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Danisco

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.

Condition or disease Intervention/treatment Phase
Obesity Hyperglycemia Insulin Resistance Dietary Supplement: Bifidobacterium animalis ssp. lactis 420 Dietary Supplement: Polydextrose Other: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Separate or Combined Supplementation of Probiotic (Bifidobacterium Lactis B420) and Polydextrose on Body Fat Mass
Study Start Date : November 2013
Primary Completion Date : May 2015
Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: 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
Dietary Supplement: Bifidobacterium animalis ssp. lactis 420
Studied as a probiotic bacteria
Other Name: B420
Active Comparator: Prebiotic
Polydextrose, 12 g once per day for six months in a sachet mixed into a smoothie drink
Dietary Supplement: Polydextrose
Studied as a prebiotic
Other Names:
  • Litesse
  • Litesse Ultra
Active Comparator: 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
Dietary Supplement: Bifidobacterium animalis ssp. lactis 420
Studied as a probiotic bacteria
Other Name: B420
Dietary Supplement: Polydextrose
Studied as a prebiotic
Other Names:
  • Litesse
  • Litesse Ultra
Placebo Comparator: Control
12 g of microcrystalline cellulose once per day for six months in a sachet to be mixed into a smoothie drink
Other: Placebo
Control
Other Name: Microcrystalline cellulose



Primary Outcome Measures :
  1. Difference in body fat mass from baseline to end-of-treatment (6 months) [ Time Frame: From baseline to end of intervention (6 months) ]
    Measured with dual-energy x-ray absorptiometry (DXA)


Secondary Outcome Measures :
  1. Change in weight (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  2. Change in BMI (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  3. Change in lean body mass [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    Total, and in individual regions of the body

  4. Hip Change in waist and/or hip circumference (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  5. Change in glycated haemoglobin (HbA1c) in blood [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  6. Change in fasting glucose levels [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  7. Change in fasting insulin levels [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  8. Change in insulin resistance [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    As determined by Homeostasis Model Assessment (HOMA)

  9. Change in inflammatory markers [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    Including high-sensitive C-reactive protein (CRP), Interleukin (IL)-6, Tumor necrosis factor (TNF)-alpha, IL-1beta, cortisol, adiponectin, leptin

  10. Change in lipopolysaccharide (LPS) concentration and soluble CD14 (sCD14) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  11. Change in LPS/sCD14 ratio [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  12. Change in blood lipids [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

  13. Change in blood pressure [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  14. Change in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyltransferase [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  15. Change in energy, fat and fiber intake [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  16. Absolute change in body fat mass [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  17. Analytical description of faecal microbiota [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  18. Body fat mass in individual regions of the body [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]

Other Outcome Measures:
  1. The differences between the treatment groups for exploratory variables [ Time Frame: Throughout the 6-month study and 1-month follow-up ]
    Fecal fat and/or energy content, change in plasma and fecal bile acids, plasma oxidated low-density lipoprotein cholesterol, LPS binding protein, Macrophage chemoattractant protein-1, Angiopoietin-like factor 4, Apolipoprotein B-48, Plasminogen activator inhibitor-1, Vascular cell adhesion molecule-1, Intercellular adhesion molecule-1, E-selectin, zonulin, blood microbiota



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978691


Locations
Finland
VL-Medi
Helsinki, Finland, 00101
Kerava healthcare center
Kerava, Finland, 04200
FinnMedi Oy
Tampere, Finland, 33520
CRST - Clinical Research Services Turku
Turku, Finland, 20521
Sponsors and Collaborators
Danisco
Investigators
Principal Investigator: Aila Rissanen, MD HYKS-instituutti Oy

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01978691     History of Changes
Other Study ID Numbers: SMR-2782
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Danisco:
Obesity
Blood glucose
Waist circumference
Lipid metabolism
Probiotics
Prebiotics
Dietary supplements
Endotoxemia

Additional relevant MeSH terms:
Insulin Resistance
Hyperglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases