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出境医 / 临床实验 / The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) 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 (QLSlimCapHL)
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 | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 : | October 22, 2019 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 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 :
- Total body fat mass relative change [ Time Frame: 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 :
- Trunk fat mass change [ Time Frame: 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)
- Waist circumference change [ Time Frame: 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)
- Android fat mass change [ Time Frame: 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)
- Lean body mass change [ Time Frame: 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 [ Time Frame: Change from baseline at 6 months ]Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)
- Fat mass change in individual body regions [ Time Frame: 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)
- Total fat mass absolute change [ Time Frame: 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 [ Time Frame: 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)
- BMI change [ Time Frame: Change from baseline at 6 months ]Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)
- Hip circumference change [ Time Frame: 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 [ Time Frame: 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:
- Food intake change [ Time Frame: 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)
- Physical activity change [ Time Frame: Change from baseline at 6 months ]Change in physical activity (IPAQ) from baseline (Visit 2) to 6 months (Visit 5)
- Daily activity change [ Time Frame: 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)
- Fasting glucose levels change [ Time Frame: Change from baseline at 6 months ]Change in fasting glucose levels from baseline (Visit 2) to 6 months (Visit 5)
- Fasting insulin levels change [ Time Frame: Change from baseline at 6 months ]Change in fasting insulin levels from baseline (Visit 2) to 6 months (Visit 5)
- Insulin resistance change [ Time Frame: Change from baseline at 6 months ]Change in insulin resistance from baseline (Visit 2) to 6 months (Visit 5)
- HbA1c change [ Time Frame: Change from baseline at 6 months ]Change in glycated hemoglobin HbA1c from baseline (Visit 2) to 6 months (Visit 5)
- Blood lipids change [ Time Frame: Change from baseline at 6 months ]Change in blood lipids from baseline (Visit 2) to 6 months (Visit 5)
- Inflammation markers change [ Time Frame: 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)
- Circulating zonulin change [ Time Frame: Change from baseline at 6 months ]Change in circulating zonulin from baseline (Visit 2) to 6 months (Visit 5)
- Barrier function and endotoxemia markers change [ Time Frame: 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)
- Fecal microbiota change [ Time Frame: Change from baseline at 6 months ]Change in fecal microbiota from baseline (Visit 2) to 6 months (Visit 5)
- Fecal metabolites change [ Time Frame: Change from baseline at 6 months ]Change in fecal metabolites from baseline (Visit 2) to 6 months (Visit 5)
- Adipose tissue biomarkers change [ Time Frame: 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
| Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- Agreement to comply with the protocol and study restrictions
- Access to Internet in addition to willingness and ability to use web-based questionnaires
- Available for all study visits
- 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.
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion Criteria:
- 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
- Use of drugs or supplements to manage body weight or body fat in the last 3 months
- Use of laxatives or fiber supplements in the past 6 weeks.
- History of chronic active inflammatory disorders
- History of bariatric surgery
- History of any chronic gastrointestinal disease (e.g. IBD) or disorders (e.g. IBS, constipation, diarrhea), or gastrointestinal reflux disease
- Regular use of non-steroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs
- Regular (more than once per week) use of proton pump inhibitors
- Recent (last 3 months) or ongoing antibiotic use
- Immunosuppression or ongoing therapy causing immunosuppression
- Use of probiotic supplements during the previous 6 weeks
- 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
- Use of vitamin D supplementation of ≥100 µg/day
- Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise)
- Weight change (increase or loss) of 3 kg during the past 3 months
- Pregnant or planning pregnancy during the study or breastfeeding
- Participation in a clinical trial with an investigational product or drug within 60 days prior to screening
- Likeliness to be noncompliant with the protocol
- No possibility of contact in case of emergency
- Illicit drug users
- Alcohol abusers
- Administrative or legal supervision
- 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
- Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
- Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
Contacts and Locations
Locations
| France | |
| CEN nutriment | Recruiting |
| Dijon, France, 21000 | |
| Contact: Sophie Cacace +334 38 37 25 67 SophieCacace@eurofins.com | |
| Contact: Pauline Leveille +334 38 37 25 61 PaulineLEVEILLE@eurofins.com | |
| Principal Investigator: Nadège Plaza, MD | |
| Sub-Investigator: Esther Milojevitch, MD | |
| Eurofins Optimed | Recruiting |
| Gières, France, 38610 | |
| Contact: Sophie Cacace +334 38 37 25 67 SophieCacace@eurofins.com | |
| Contact: Pauline Leveille + 33 438 37 25 61 PaulineLEVEILLE@eurofins.com | |
| Principal Investigator: Yves Donazzolo, MD, MSc | |
| Sub-Investigator: Mathilde Latreille Barbier, MD | |
| Sub-Investigator: Valentina Hodaj, MD | |
| Biofortis SAS | Recruiting |
| Saint-Herblain, France, 44800 | |
| Contact: Sophie Cacace +334 38 37 25 67 SophieCacace@eurofins.com | |
| Contact: Pauline Leveille +334 38 37 25 61 PaulineLEVEILLE@eurofins.com | |
| Principal Investigator: Isabelle Metreau, MD | |
| Sub-Investigator: Marie Deciron, MD | |
| Spain | |
| Cap Vallcarca | Recruiting |
| Barcelona, Spain, 08023 | |
| Contact: Silvia Crespo +34 930 16 01 26 screspo@syntaxfs.com | |
| Contact: Marta Rafart +34 930 16 01 26 mrafart@syntaxfs.com | |
| Principal Investigator: Alexis Tena Domingo, MD | |
| CAP Centelles | Recruiting |
| Barcelona, Spain, 8540 | |
| Contact: Silvia Crespo +34 930 16 01 screspo@syntaxfs.com | |
| Contact: Marta Rafart +34 930 16 01 26 mrafart@syntaxfs.com | |
| Principal Investigator: Xavier Farres, MD | |
| Sub-Investigator: Helena Ferrer, MD | |
| CAP Hostalets | Recruiting |
| Barcelona, Spain | |
| Contact: Silvia Crespo +34 930 16 01 26 screspo@syntaxfs.com | |
| Contact: Marta Rafart +34 930 16 01 26 mrafart@syntaxfs.com | |
| Principal Investigator: Xavier Farres, MD | |
| Sub-Investigator: Helena Ferrer, MD | |
| CAP Perelada | Withdrawn |
| Girona, Spain, 17491 | |
| CAP Muralles | Recruiting |
| Tarragona, Spain, 43002 | |
| Contact: Silvia Crespo +34 930 16 01 26 screspo@syntaxfs.com | |
| Contact: Marta Rafart +34 930 16 01 26 mrafart@syntaxfs.com | |
| Principal Investigator: Cristina Picazo, MD | |
Sponsors and Collaborators
Danisco France SAS
Eurofins Optimed
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 18, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | August 31, 2020 | ||||
| Actual Study Start Date ICMJE | October 22, 2019 | ||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Total body fat mass relative change [ Time Frame: 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
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention | ||||
| Official Title ICMJE | 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 | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Other |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Dietary Supplement: Daily intake of study product
Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
418 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | September 2021 | ||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | France, Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03934229 | ||||
| Other Study ID Numbers ICMJE | 2018-A03140-55 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Danisco France SAS | ||||
| Study Sponsor ICMJE | Danisco France SAS | ||||
| Collaborators ICMJE | Eurofins Optimed | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Danisco France SAS | ||||
| Verification Date | August 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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