CClinicalTrials.gg
CompletedNCT02962583Updated Sep 2, 2020

The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants

A Phase 2 interventional study of Weight loss and Probiotic Formula in Obesity, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Laval University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Limited interventional human studies suggest that probiotic supplementation may be a beneficial strategy for promoting weight loss when added to a nutritional intervention via their effects on lipid absorption and metabolic signaling molecules. The purpose of this study is to evaluate the effects of addition of a probiotic supplementation to a weight loss intervention on body weight, body composition and overall health in overweight adults.

02

Conditions studied

  • Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 152 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 18 to 55 years
  • BMI between 27.0 and 39.9 kg/m2
  • Sedentary to moderate active (less than 30 minutes of physical activity, 3 times per week)
  • Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits
  • Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substance for body weight control
  • Willingness and ability to provide informed consent in French
  • Willingness to receive random assignment to probiotic or placebo supplementation
  • Committed to losing weight over the 12-week study period

Exclusion criteria

Exclusion Criteria:

  • Smokers
  • Use of another investigational product within three months of the pre-baseline period.
  • Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.

    • Women of child-bearing potential not using effective contraception which include:
    • Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants
    • Intrauterine devices (IUD) or Intrauterine system (IUS)
    • Tubal ligation
    • Vasectomy of partner
    • Double barrier method (use of physical barrier by both partners, e.g. male condom and diaphragm, male condom and cervical cap)
  • Positive pregnancy test in women of child-bearing potential
  • Menopausal women
  • Allergic to milk, soy, or yeast
  • Weight gain or loss of at least 10 lbs in previous three months
  • Inflammatory bowel syndrome, celiac disease, short bowel syndrome, or any other malabsorptive syndrome
  • Uncontrolled angina within the past six months
  • Insulin-dependent diabetes (oral medications are not exclusionary)
  • Serious and/or unstable medical conditions (e.g. cardiovascular, renal, lung, psychiatric illness, bleeding disorders, etc.)
  • Cancer treatment (radiation, chemotherapy, surgery) within past six months or any other treatment or condition known to weaken the immune system (such as systemic corticosteroids or HIVIAIDS).
  • Any physical condition deemed likely to significantly interfere with individuals' ability to participate in a nutritional intervention.
  • Currently or at any point during the study participating in Weight Watcher's or another weight loss program or taking a medication for weight loss.
  • Under antibiotics or treatments (medication or nutritional program) affecting body weight Intake and/or energy expenditure
  • History of drug or alcohol (> 9 drinks weekly) abuse
  • Abnormal thyroid hormone levels
  • Immune-compromised conditions
  • Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
152 participants (actual)

Study arms

  • Experimental
    Probiotic

    Daily probiotic consumption

    Other: Weight loss · Drug: Probiotic Formula

  • Placebo comparator
    Placebo

    Daily placebo consumption

    Other: Weight loss · Drug: Placebos

Interventions

  • OtherWeight loss
  • DrugProbiotic Formula
  • DrugPlacebos
06

What researchers measure

Primary outcomes

  1. Change from Baseline body weight at 12 weeks

    Time frame: 12 weeks

Secondary outcomes

  1. Change from Baseline BMI at 12 weeks

    Time frame: 12 weeks

  2. Change from Baseline waist circumference data at 12 weeks

    Time frame: 12 weeks

  3. Change from Baseline sagittal abdominal diameter data at 12 weeks

    Time frame: 12 weeks

  4. Change from Baseline body composition at 12 weeks

    DXA

    Time frame: 12 weeks

  5. Change from Baseline stress level at 12 weeks

    Questionnaire

    Time frame: 12 weeks

  6. Change from Baseline anxiety level at 12 weeks

    Questionnaire

    Time frame: 12 weeks

  7. Change from Baseline depression symptoms at 12 weeks

    Questionnaire

    Time frame: 12 weeks

  8. Change from Baseline sleeping habits at 12 weeks

    Questionnaire

    Time frame: 12 weeks

  9. Change from Baseline intestinal microbiota composition at 12 weeks

    Changes in the concentrations of the probiotic strains in the stools will be measured with strain specific DNA in fecal samples.

    Time frame: 12 weeks

  10. Change from Baseline C-reactive protein at 12 weeks

    Time frame: 12 weeks

  11. Change from Baseline TNF-a at 12 weeks

    Time frame: 12 weeks

  12. Change from Baseline interleukin-6 at 12 weeks

    Time frame: 12 weeks

  13. Change from Baseline lipopolysaccharide (LPS) at 12 weeks

    Time frame: 12 weeks

07

Study locations

1 site
  • PEPS - Université Laval
    Québec, Quebec G1V0A6, Canada
08

References and documents

Publications

  • Choi BS, Brunelle L, Pilon G, Cautela BG, Tompkins TA, Drapeau V, Marette A, Tremblay A. Lacticaseibacillus rhamnosus HA-114 improves eating behaviors and mood-related factors in adults with overweight during weight loss: a randomized controlled trial. Nutr Neurosci. 2023 Jul;26(7):667-679. doi: 10.1080/1028415X.2022.2081288. Epub 2022 Jun 17. PubMed 35714163 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02962583
Lead sponsor
Laval University
Collaborators
Lallemand Health Solutions
Responsible party
Angelo Tremblay (Professor, Laval University) — Principal investigator
First posted
Nov 11, 2016
Start date
Jan 2017
Primary completion
Jun 6, 2019
Completion
Jun 6, 2019
Last update
Sep 2, 2020

Study contacts

Angelo Tremblay, Ph.D
study director · Laval University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion