Effect of Study Probiotics on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention

Obesity Clinical Trial

— QLSlimCapHL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934229
• Other study ID #: 2018-A03140-55
• Status: Completed
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: January 14, 2022

Study information

• Verified date: October 2022
• Source: Danisco France SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Daily intake of study product
Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period

Locations

Country	Name	City	State
France	CEN nutriment	Dijon
France	Eurofins Optimed	Gières
France	Biofortis SAS	Saint-Herblain
Spain	CAP Centelles	Barcelona
Spain	CAP Hostalets	Barcelona
Spain	Cap Vallcarca	Barcelona
Spain	CAP Muralles	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Danisco France SAS	Eurofins Optimed

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food intake change	Change in food intake from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Other	Physical activity change	Change in physical activity (IPAQ) from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Daily activity change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Other	Fasting glucose levels change	Change in fasting glucose levels from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Fasting insulin levels change	Change in fasting insulin levels from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Insulin resistance change	Change in insulin resistance from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	HbA1c change	Change in glycated hemoglobin HbA1c from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Blood lipids change	Change in blood lipids from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Inflammation markers change	Change in inflammation markers, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Circulating zonulin change	Change in circulating zonulin from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Barrier function and endotoxemia markers change	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)	Change from baseline at 6 months
Other	Fecal microbiota change	Change in fecal microbiota from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Fecal metabolites change	Change in fecal metabolites from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Other	Adipose tissue biomarkers change	Change in adipose tissue biomarkers, as specified in Section 4.2.8, from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Primary	Total body fat mass relative change	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	Change from baseline at 6 months
Secondary	Trunk fat mass change	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)	Change from baseline at 2 months, 4 months and 6 months
Secondary	Waist circumference change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	Android fat mass change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	Lean body mass change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	Energy intake change	Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Secondary	Fat mass change in individual body regions	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	Total fat mass absolute change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	Body weight change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	BMI change	Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)	Change from baseline at 6 months
Secondary	Hip circumference change	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)	Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)
Secondary	Total fat mass relative change	Change in total body fat mass relative change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4)	Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4)