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

• Sponsor: Danisco France SAS (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03934229
• Collaborator: Eurofins Optimed (Industry)
• Enrollment: 418
• Locations: 8
• Arms: 2
• Anticipated Duration (Months): 22.3
• Patients Per Site: 52.3
• Patients Per Site Per Month: 2.3

Study Details

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	Intervention/Treatment	Phase
Overweight; Obesity	Dietary Supplement: Daily intake of study product	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 22, 2019
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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. Food intake change [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)

2. Physical activity change [Change from baseline at 6 months]

   Change in physical activity (IPAQ) from baseline (Visit 2) to 6 months (Visit 5)

3. Daily activity change [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)

4. Fasting glucose levels change [Change from baseline at 6 months]

   Change in fasting glucose levels from baseline (Visit 2) to 6 months (Visit 5)

5. Fasting insulin levels change [Change from baseline at 6 months]

   Change in fasting insulin levels from baseline (Visit 2) to 6 months (Visit 5)

6. Insulin resistance change [Change from baseline at 6 months]

   Change in insulin resistance from baseline (Visit 2) to 6 months (Visit 5)

7. HbA1c change [Change from baseline at 6 months]

   Change in glycated hemoglobin HbA1c from baseline (Visit 2) to 6 months (Visit 5)

8. Blood lipids change [Change from baseline at 6 months]

   Change in blood lipids from baseline (Visit 2) to 6 months (Visit 5)

9. Inflammation markers change [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 [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 [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 [Change from baseline at 6 months]

    Change in fecal microbiota from baseline (Visit 2) to 6 months (Visit 5)

13. Fecal metabolites change [Change from baseline at 6 months]

    Change in fecal metabolites from baseline (Visit 2) to 6 months (Visit 5)

14. Adipose tissue biomarkers change [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

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	CEN nutriment	Dijon		France	21000
2	Eurofins Optimed	Gières		France	38610
3	Biofortis SAS	Saint-Herblain		France	44800
4	Cap Vallcarca	Barcelona		Spain	08023
5	CAP Centelles	Barcelona		Spain	8540
6	CAP Hostalets	Barcelona		Spain
7	CAP Perelada	Girona		Spain	17491
8	CAP Muralles	Tarragona		Spain	43002

Sponsors and Collaborators

• Danisco France SAS
• Eurofins Optimed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Danisco France SAS
• ClinicalTrials.gov Identifier: NCT03934229
• Other Study ID Numbers: 2018-A03140-55
• First Posted: May 1, 2019
• Last Update Posted: Aug 31, 2020
• Last Verified: Aug 1, 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

Study Results

No Results Posted as of Aug 31, 2020