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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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ClinicalTrials.gov Identifier: NCT02962583
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
Angelo Tremblay, Laval University

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE November 11, 2016
Last Update Posted Date September 2, 2020
Study Start Date  ICMJE January 2017
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
Change from Baseline body weight at 12 weeks [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • Change from Baseline BMI at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline waist circumference data at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline sagittal abdominal diameter data at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline body composition at 12 weeks [ Time Frame: 12 weeks ]
    DXA
  • Change from Baseline stress level at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline anxiety level at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline depression symptoms at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline sleeping habits at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline intestinal microbiota composition at 12 weeks [ Time Frame: 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 [ Time Frame: 12 weeks ]
  • Change from Baseline TNF-a at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline interleukin-6 at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline lipopolysaccharide (LPS) at 12 weeks [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • Change from Baseline BMI at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline waist circumference data at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline sagittal abdominal diameter data at 12 weeks [ Time Frame: 12 weeks ]
  • Change from Baseline body composition at 12 weeks [ Time Frame: 12 weeks ]
    DXA
  • Change from Baseline stress level at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline anxiety level at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline depression symptoms at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline sleeping habits at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire
  • Change from Baseline intestinal microbiota composition at 12 weeks [ Time Frame: 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 markers of inflammation at 12 weeks [ Time Frame: 12 weeks ]
    C-reactive protein, TNF-a, interleukin-6 and LPS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Addition of Probiotic Consumption to a Nutritional Intervention and Caloric Restriction on Body Weight and Composition in Overweight Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: Weight loss
  • Drug: Probiotic Formula
  • Drug: Placebos
Study Arms  ICMJE
  • Experimental: Probiotic
    Daily probiotic consumption
    Interventions:
    • Other: Weight loss
    • Drug: Probiotic Formula
  • Placebo Comparator: Placebo
    Daily placebo consumption
    Interventions:
    • Other: Weight loss
    • Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2016)
152
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 6, 2019
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02962583
Other Study ID Numbers  ICMJE CLIN-21-012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Angelo Tremblay, Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE Lallemand Health Solutions
Investigators  ICMJE
Study Director: Angelo Tremblay, Ph.D Laval University
PRS Account Laval University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP