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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Weight loss
Probiotic Formula
Placebos
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • PEPS - Université Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Daily probiotic consumption

Daily placebo consumption

Outcomes

Primary Outcome Measures

Change from Baseline body weight at 12 weeks

Secondary Outcome Measures

Change from Baseline BMI at 12 weeks
Change from Baseline waist circumference data at 12 weeks
Change from Baseline sagittal abdominal diameter data at 12 weeks
Change from Baseline body composition at 12 weeks
DXA
Change from Baseline stress level at 12 weeks
Questionnaire
Change from Baseline anxiety level at 12 weeks
Questionnaire
Change from Baseline depression symptoms at 12 weeks
Questionnaire
Change from Baseline sleeping habits at 12 weeks
Questionnaire
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.
Change from Baseline C-reactive protein at 12 weeks
Change from Baseline TNF-a at 12 weeks
Change from Baseline interleukin-6 at 12 weeks
Change from Baseline lipopolysaccharide (LPS) at 12 weeks

Full Information

First Posted
November 2, 2016
Last Updated
August 31, 2020
Sponsor
Laval University
Collaborators
Lallemand Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT02962583
Brief Title
The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants
Official Title
The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants: A Randomized, Double-blind, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Lallemand Health Solutions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Daily probiotic consumption
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily placebo consumption
Intervention Type
Other
Intervention Name(s)
Weight loss
Intervention Type
Drug
Intervention Name(s)
Probiotic Formula
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Change from Baseline body weight at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline BMI at 12 weeks
Time Frame
12 weeks
Title
Change from Baseline waist circumference data at 12 weeks
Time Frame
12 weeks
Title
Change from Baseline sagittal abdominal diameter data at 12 weeks
Time Frame
12 weeks
Title
Change from Baseline body composition at 12 weeks
Description
DXA
Time Frame
12 weeks
Title
Change from Baseline stress level at 12 weeks
Description
Questionnaire
Time Frame
12 weeks
Title
Change from Baseline anxiety level at 12 weeks
Description
Questionnaire
Time Frame
12 weeks
Title
Change from Baseline depression symptoms at 12 weeks
Description
Questionnaire
Time Frame
12 weeks
Title
Change from Baseline sleeping habits at 12 weeks
Description
Questionnaire
Time Frame
12 weeks
Title
Change from Baseline intestinal microbiota composition at 12 weeks
Description
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
Title
Change from Baseline C-reactive protein at 12 weeks
Time Frame
12 weeks
Title
Change from Baseline TNF-a at 12 weeks
Time Frame
12 weeks
Title
Change from Baseline interleukin-6 at 12 weeks
Time Frame
12 weeks
Title
Change from Baseline lipopolysaccharide (LPS) at 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Tremblay, Ph.D
Organizational Affiliation
Laval University
Official's Role
Study Director
Facility Information:
Facility Name
PEPS - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V0A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35714163
Citation
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.
Results Reference
derived

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

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