Effect of Study Probiotics on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention (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: A Randomized, Double-blind, Placebo-controlled, Multi-center Study

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)

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: Daily intake of study product

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • CEN Nutriment
  • Gières, France, 38610
    • Eurofins Optimed
  • Saint-Herblain, France, 44800
    • Biofortis Sas
• Spain
  • Barcelona, Spain, 08023
    • CAP Vallcarca
  • Barcelona, Spain, 8540
    • CAP Centelles
  • Barcelona, Spain
    • CAP Hostalets
  • Tarragona, Spain, 43002
    • CAP Muralles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
Energy intake change	Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
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)
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)
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)
BMI change	Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)	Change from baseline at 6 months
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Physical activity change	Change in physical activity (IPAQ) from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
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)
Fasting glucose levels change	Change in fasting glucose levels from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Fasting insulin levels change	Change in fasting insulin levels from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Insulin resistance change	Change in insulin resistance from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
HbA1c change	Change in glycated hemoglobin HbA1c from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Blood lipids change	Change in blood lipids from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
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
Circulating zonulin change	Change in circulating zonulin from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
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
Fecal microbiota change	Change in fecal microbiota from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
Fecal metabolites change	Change in fecal metabolites from baseline (Visit 2) to 6 months (Visit 5)	Change from baseline at 6 months
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

Collaborators and Investigators

• Sponsor: Danisco France SAS
• Collaborators: Eurofins Optimed

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Overweight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 2018-A03140-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No