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OverweightQLSlimCapHLNCT03934229

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

A study testing Daily intake of study product in people with Overweight and Obesity, run by Danisco France SAS at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
Daily intake of study product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
418 participants
Where
7 sitesin 2 countries
Study dates
22 Oct 2019to 14 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Spain4 sites

  • Cap Vallcarca

    Barcelona, 08023

  • CAP Centelles

    Barcelona, 8540

  • CAP Hostalets

    Barcelona

  • CAP Muralles

    Tarragona, 43002

Other trials in Spain

France3 sites

  • CEN nutriment

    Dijon, 21000

  • Eurofins Optimed

    Gières, 38610

  • Biofortis SAS

    Saint-Herblain, 44800

Other trials in France

About this study

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

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)

Conditions
Overweight, Obesity
Being tested
Daily intake of study product
Keywords
Overweight, Obesity
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily intake of study productDietary supplement

    Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period

Study groups in NCT03934229
Study groupRoleWhat they receive
Group ActiveExperimentalBifidobacterium animalis ssp. lactis 420 at 1*10^10 colony forming units (CFU) per day
Receives: Dietary Supplement: Daily intake of study product
Group PlaceboPlacebo comparatorPlacebo
Receives: Dietary Supplement: Daily intake of study product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change from baseline at 6 months

Secondary outcomes (11)

  1. 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)

    Measured: Change from baseline at 2 months, 4 months and 6 months

  2. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  3. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  4. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  5. Energy intake change

    Change in energy intake from baseline (Visit 2) to 6 months (Visit 5)

    Measured: Change from baseline at 6 months

  6. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  7. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  8. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  9. BMI change

    Change in BMI from baseline (Visit 2) to 6 months (Visit 5) (absolute and relative)

    Measured: Change from baseline at 6 months

  10. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), 4 months (Visit 4) and 6 months (Visit 5)

  11. 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)

    Measured: Change from baseline (Visit 2) to 2 months (Visit 3), and 4 months (Visit 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start22 Oct 2019
  3. Primary completion14 Jan 2022
  4. Study completion14 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03934229
Sponsor's protocol ID
2018-A03140-55
Acronym
QLSlimCapHL
Status last verified
Oct 2022
First submitted
18 Apr 2019
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Daily intake of study product in people with Overweight and Obesity, run by Danisco France SAS at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total body fat mass relative change (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03934229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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