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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Dietary Supplement: Daily intake of study product

• Registration Number: NCT03934229
• Lead Sponsor: Danisco France SAS

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-10-22
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Active	Daily intake of study product	Bifidobacterium animalis ssp. lactis 420 at 1\*10\^10 colony forming units (CFU) per day
Group Placebo	Daily intake of study product	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)
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)
Energy intake change	Change from baseline at 6 months	Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)
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)
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)
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)
BMI change	Change from baseline at 6 months	Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)
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)
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)

Trial Locations

Locations (7)

Eurofins Optimed; 🇫🇷 Gières, France

Biofortis SAS; 🇫🇷 Saint-Herblain, France

Cap Vallcarca; 🇪🇸 Barcelona, Spain

CAP Hostalets; 🇪🇸 Barcelona, Spain

CAP Centelles; 🇪🇸 Barcelona, Spain

CAP Muralles; 🇪🇸 Tarragona, Spain

CEN nutriment; 🇫🇷 Dijon, France