NCT03934229

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 22, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

April 18, 2019

Last Update Submit

October 10, 2022

Conditions

OverweightObesity

Keywords

OverweightObesity

Outcome Measures

Primary Outcomes (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

    Change from baseline at 6 months

Secondary Outcomes (11)

  • Trunk fat mass change

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

  • Waist circumference change

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

  • Android fat mass change

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

  • Lean body mass change

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

  • Energy intake change

    Change from baseline at 6 months

  • +6 more secondary outcomes

Other Outcomes (14)

  • Food intake change

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

  • Physical activity change

    Change from baseline at 6 months

  • Daily activity change

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

  • +11 more other outcomes

Study Arms (2)

Group Active

EXPERIMENTAL

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

Dietary Supplement: Daily intake of study product

Group Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Daily intake of study product

Interventions

Daily intake of study productDIETARY_SUPPLEMENT

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

Group ActiveGroup Placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CEN nutriment

Dijon, 21000, France

Location

Eurofins Optimed

Gières, 38610, France

Location

Biofortis SAS

Saint-Herblain, 44800, France

Location

Cap Vallcarca

Barcelona, 08023, Spain

Location

CAP Centelles

Barcelona, 8540, Spain

Location

CAP Hostalets

Barcelona, Spain

Location

CAP Muralles

Tarragona, 43002, Spain

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

May 1, 2019

Study Start

October 22, 2019

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

FR(3)ES(4)