NCT02962583

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Jan 2017

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

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

November 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

November 2, 2016

Last Update Submit

August 31, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline body weight at 12 weeks

    12 weeks

Secondary Outcomes (13)

  • Change from Baseline BMI at 12 weeks

    12 weeks

  • Change from Baseline waist circumference data at 12 weeks

    12 weeks

  • Change from Baseline sagittal abdominal diameter data at 12 weeks

    12 weeks

  • Change from Baseline body composition at 12 weeks

    12 weeks

  • Change from Baseline stress level at 12 weeks

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Probiotic

EXPERIMENTAL

Daily probiotic consumption

Other: Weight lossDrug: Probiotic Formula

Placebo

PLACEBO COMPARATOR

Daily placebo consumption

Other: Weight lossDrug: Placebos

Interventions

Weight lossOTHER
PlaceboProbiotic
Probiotic FormulaDRUG
Probiotic
PlacebosDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PEPS - Université Laval

Québec, Quebec, G1V0A6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 35714163DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Angelo Tremblay, Ph.D

    Laval University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 11, 2016

Study Start

January 1, 2017

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)