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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

Tracking Information
First Submitted Date  ICMJE November 1, 2013
First Posted Date  ICMJE November 7, 2013
Last Update Posted Date February 2, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • Change in weight (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in BMI (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in lean body mass [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    Total, and in individual regions of the body
  • Hip Change in waist and/or hip circumference (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in glycated haemoglobin (HbA1c) in blood [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in fasting glucose levels [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in fasting insulin levels [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in insulin resistance [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    As determined by Homeostasis Model Assessment (HOMA)
  • 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
  • Change in lipopolysaccharide (LPS) concentration and soluble CD14 (sCD14) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in LPS/sCD14 ratio [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in blood lipids [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
  • Change in blood pressure [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyltransferase [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in energy, fat and fiber intake [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Absolute change in body fat mass [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Analytical description of faecal microbiota [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Body fat mass in individual regions of the body [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
  • Change in weight (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in BMI (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in lean body mass [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Hip Change in waist and/or hip circumference (absolute and relative) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in glycated haemoglobin (HbA1c) in blood [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in fasting glucose levels [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in fasting insulin levels [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in insulin resistance [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    As determined by Homeostasis Model Assessment (HOMA)
  • 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
  • Change in lipopolysaccharide (LPS) concentration and soluble CD14 (sCD14) [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in LPS/sCD14 ratio [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in blood lipids [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
  • Change in blood pressure [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyltransferase [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Change in energy, fat and fiber intake [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Absolute change in body fat mass [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
  • Analytical description of faecal microbiota [ Time Frame: Months 0, 2, 4, 6 and 7 (follow-up) ]
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass
Official Title  ICMJE The Effect of Separate or Combined Supplementation of Probiotic (Bifidobacterium Lactis B420) and Polydextrose on Body Fat Mass
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Obesity
  • Hyperglycemia
  • Insulin Resistance
Intervention  ICMJE
  • 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
  • Other: Placebo
    Control
    Other Name: Microcrystalline cellulose
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Bifidobacterium animalis ssp. lactis 420
  • Active Comparator: Prebiotic
    Polydextrose, 12 g once per day for six months in a sachet mixed into a smoothie drink
    Intervention: Dietary Supplement: Polydextrose
  • 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
    Interventions:
    • Dietary Supplement: Bifidobacterium animalis ssp. lactis 420
    • Dietary Supplement: Polydextrose
  • Placebo Comparator: Control
    12 g of microcrystalline cellulose once per day for six months in a sachet to be mixed into a smoothie drink
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2014)
225
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2013)
200
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01978691
Other Study ID Numbers  ICMJE SMR-2782
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Danisco
Study Sponsor  ICMJE Danisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aila Rissanen, MD HYKS-instituutti Oy
PRS Account Danisco
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP