Completed

QLSlimCapHLBifidobacterium Animalis Ssp. Lactis 420 (B420) Impact on Body Fat in Overweight and Obese Individuals Undergoing Healthy Lifestyle Intervention

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What is being tested

Daily intake of study product

Dietary Supplement
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 20 to 65 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: October 2019
See protocol details

Summary

Principal SponsorDanisco France SAS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2019

Actual date on which the first participant was enrolled.

This study focuses on overweight and obese individuals who are following a healthy lifestyle, which includes a calorie-reduced diet and an increase in daily activity. The main goal is to evaluate the effect of a specific probiotic, Bifidobacterium Animalis Ssp. Lactis 420 (B420), on body fat mass. The importance of this study lies in understanding if this probiotic could enhance the benefits of a healthy lifestyle, potentially offering a new approach to weight management. Participants in this study are randomly assigned to either receive the B420 probiotic or a placebo, neither the participants nor the researchers know who is receiving what, ensuring unbiased results. Over a period of 6 months, participants will incorporate the probiotic or placebo into their daily routine. The study measures the change in total body fat mass from the beginning to the end of the study. The primary outcome is the difference in this change between the group receiving the probiotic and the group receiving the placebo.

Official TitleThe 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
NCT03934229
Principal SponsorDanisco France SAS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

418 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

9 inclusion criteria required to participate
Voluntary, written, signed, informed consent to participate in the study
Male or female, age between 20 to 65 (inclusive)
BMI between 28.0 and 34.9 (inclusive), of which 1:1 overweight (28.0-29.9):obese (30-34.9)
Waist circumference for men of > 102 cm or for women of > 88 cm
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28 exclusion criteria prevent from participating
Diagnosed and pharmacologically-treated type 1 and type 2 diabetes (fasting blood glucose ≥ 7 mmol/l)
Use of medication/supplements for blood glucose control
Pharmacologically-treated (medication/supplements) hypertension or dyslipidemia
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Bifidobacterium animalis ssp. lactis 420 at 1\*10\^10 colony forming units (CFU) per day

Group II

Placebo
Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

CEN nutriment

Dijon, FranceOpen CEN nutriment in Google Maps
Suspended

Eurofins Optimed

Gières, France
Suspended

Biofortis SAS

Saint-Herblain, France
Suspended

Cap Vallcarca

Barcelona, Spain
Completed7 Study Centers