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The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention

  • Clinicaltrials.gov identifier

    NCT03934229

  • Recruitment Status

    Recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    August 31, 2020

Study Description

Brief summary:

A randomized, double-blind, placebo-controlled, multi-center, parallel group study on overweight and obese individuals following healthy lifestyle consisting of calorie-reduced diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once compared to the baseline steps)

  • Condition or Disease:Obesity
    Overweight
  • Intervention/Treatment: Dietary Supplement: Daily intake of study product
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 418 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Other
  • Official Title: The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention: A Randomized, Double-blind, Placebo-controlled, Multi-center Study
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: September 2021
  • Estimated Study Completion Date: September 2021

Arms and interventions

Arm Intervention/treatment
Experimental: Group Active
Bifidobacterium animalis ssp. lactis 420 at 1*10^10 colony forming units (CFU) per day
Dietary Supplement: Daily intake of study product
Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period
Placebo Comparator: Group Placebo
Placebo
Dietary Supplement: Daily intake of study product
Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period

Outcome Measures

  • Primary Outcome Measures: 1. Total body fat mass relative change [ Time Frame: Change from baseline at 6 months ]
    Difference in total body fat mass relative change from baseline (Visit 2) to 6 months of product intake (Visit 5) between the active vs. placebo group
  • Secondary Outcome Measures: 1. Trunk fat mass change [ Time Frame: Change from baseline at 2 months, 4 months and 6 months ]
    Change in trunk fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 2. Waist circumference change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in waist circumference from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 3. Android fat mass change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in android fat mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 4. Lean body mass change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in lean body mass from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 5. Energy intake change [ Time Frame: Change from baseline at 6 months ]
    Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)
  • 6. Fat mass change in individual body regions [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in fat mass in other individual body regions from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 7. Total fat mass absolute change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in total body fat mass absolute change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
  • 8. Body weight change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in body weight from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 9. BMI change [ Time Frame: Change from baseline at 6 months ]
    Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)
  • 10. Hip circumference change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in hip circumference from baseline (Visit 2) to, 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) (absolute and relative)
  • 11. Total fat mass relative change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4) ]
    Change in total body fat mass relative change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4)
  • Other Outcome Measures: 1. Fasting insulin levels change [ Time Frame: Change from baseline at 6 months ]
    Change in fasting insulin levels from baseline (Visit 2) to 6 months (Visit 5)
  • 2. Food intake change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in food intake from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
  • 3. Physical activity change [ Time Frame: Change from baseline at 6 months ]
    Change in physical activity (IPAQ) from baseline (Visit 2) to 6 months (Visit 5)
  • 4. Daily activity change [ Time Frame: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5) ]
    Change in daily activity (steps, pedometer/accelerometer) from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
  • 5. Fasting glucose levels change [ Time Frame: Change from baseline at 6 months ]
    Change in fasting glucose levels from baseline (Visit 2) to 6 months (Visit 5)
  • 6. Insulin resistance change [ Time Frame: Change from baseline at 6 months ]
    Change in insulin resistance from baseline (Visit 2) to 6 months (Visit 5)
  • 7. HbA1c change [ Time Frame: Change from baseline at 6 months ]
    Change in glycated hemoglobin HbA1c from baseline (Visit 2) to 6 months (Visit 5)
  • 8. Blood lipids change [ Time Frame: Change from baseline at 6 months ]
    Change in blood lipids from baseline (Visit 2) to 6 months (Visit 5)
  • 9. Inflammation markers change [ Time Frame: Change from baseline at 6 months ]
    Change in inflammation markers, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5)
  • 10. Circulating zonulin change [ Time Frame: Change from baseline at 6 months ]
    Change in circulating zonulin from baseline (Visit 2) to 6 months (Visit 5)
  • 11. Barrier function and endotoxemia markers change [ Time Frame: Change from baseline at 6 months ]
    Change in markers of gut barrier function and endotoxemia, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5)
  • 12. Fecal microbiota change [ Time Frame: Change from baseline at 6 months ]
    Change in fecal microbiota from baseline (Visit 2) to 6 months (Visit 5)
  • 13. Fecal metabolites change [ Time Frame: Change from baseline at 6 months ]
    Change in fecal metabolites from baseline (Visit 2) to 6 months (Visit 5)
  • 14. Adipose tissue biomarkers change [ Time Frame: Change from baseline at 6 months ]
    Change in adipose tissue biomarkers, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5)

Eligibility Criteria

  • Ages Eligible for Study: 20 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Voluntary, written, signed, informed consent to participate in the study

2. Male or female, age between 20 to 65 (inclusive)

3. BMI between 28.0 and 34.9 (inclusive), of which 1:1 overweight (28.0-29.9):obese
(30-34.9)

4. Waist circumference for men of > 102 cm or for women of > 88 cm

5. Agreement to comply with the protocol and study restrictions

6. Access to Internet in addition to willingness and ability to use web-based
questionnaires

7. Available for all study visits

8. Females of child-bearing potential required to provide a negative urine pregnancy test
and agree to use a medically-approved method of birth control, eg. all of the
following are approved: birth control pill, patch, shot, vaginal ring, mini pill,
long-acting reversible contraception (LARC) meaning hormonal intrauterine device,
nonhormonal intrauterine device with copper, subdermal contraceptive implant, condoms,
cervical cap, diaphragm.

9. Covered by Health Insurance System and / or in compliance with the recommendations of
National Law in force relating to biomedical research.

Exclusion Criteria:

1. Diagnosed and pharmacologically-treated type 1 and type 2 diabetes (fasting blood
glucose ≥ 7 mmol/l)

2. Use of medication/supplements for blood glucose control

3. Pharmacologically-treated (medication/supplements) hypertension or dyslipidemia

4. Cardiovascular disease, hypertensive retinopathy, left ventricular dysfunction,
secondary hypertension, liver dysfunction/disease, kidney dysfunction/disease,
dementia, thyroid disease, pancreatic disease, history of cancer within past 5 years
(excluding basal cell carcinoma), anemia, or any other disease or condition which, in
the Investigator's opinion, could interfere with the results of the study or the
safety of the subject

5. Use of drugs or supplements to manage body weight or body fat in the last 3 months

6. Use of laxatives or fiber supplements in the past 6 weeks.

7. History of chronic active inflammatory disorders

8. History of bariatric surgery

9. History of any chronic gastrointestinal disease (e.g. IBD) or disorders (e.g. IBS,
constipation, diarrhea), or gastrointestinal reflux disease

10. Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled
corticosteroids, or systemic immunomodulatory drugs

11. Regular (more than once per week) use of proton pump inhibitors

12. Recent (last 3 months) or ongoing antibiotic use

13. Immunosuppression or ongoing therapy causing immunosuppression

14. Use of probiotic supplements during the previous 6 weeks

15. Significant change in tobacco, snuff, nicotine and e-cigarette use habits in the past
3 months or planned cessation of the use of these products during the trial

16. Use of vitamin D supplementation of ≥100 µg/day

17. Active or recent (last 3 months) participation in a weight loss program (diet and/or
exercise)

18. Weight change (increase or loss) of 3 kg during the past 3 months

19. Pregnant or planning pregnancy during the study or breastfeeding

20. Participation in a clinical trial with an investigational product or drug within 60
days prior to screening

21. Likeliness to be noncompliant with the protocol

22. No possibility of contact in case of emergency

23. Illicit drug users

24. Alcohol abusers

25. Administrative or legal supervision

26. Subject who would receive more than 4500 euros as indemnities for his participation in
biomedical research within the 12 last months, including the indemnities for the
present study

27. Other reasons that, in the opinion of the Investigator, make the participant
unsuitable for enrolment

28. Other reasons that, in the opinion of the Investigator, make the participant
unsuitable for enrolment

Contacts and Locations

Contacts

Locations

France
CEN nutriment
Dijon

France
Eurofins Optimed
Gières

France
Biofortis SAS
Saint-Herblain

Spain
Cap Vallcarca
Barcelona

Spain
CAP Centelles
Barcelona

Spain
CAP Hostalets
Barcelona

Spain
CAP Perelada
Girona

Spain
CAP Muralles
Tarragona

Sponsors and Collaborators

Danisco France SAS

Eurofins Optimed

More Information

  • Responsible Party: Danisco France SAS
  • ClinicalTrials.gov Identifier: NCT03934229 History of Changes
  • Other Study ID Numbers: 2018-A03140-55
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: August 31, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Danisco France SAS: Overweight Obesity
  • Additional relevant MeSH terms: Overweight