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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 : Recruiting
First Posted : November 11, 2016
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
Angelo Tremblay, Laval University

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.

Condition or disease Intervention/treatment Phase
Obesity Other: Weight loss Drug: Probiotic Formula Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Probiotic
Daily probiotic consumption
Other: Weight loss
Drug: Probiotic Formula
Placebo Comparator: Placebo
Daily placebo consumption
Other: Weight loss
Drug: Placebos



Primary Outcome Measures :
  1. Change from Baseline body weight at 12 weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: 12 weeks ]
    DXA

  5. Change from Baseline stress level at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire

  6. Change from Baseline anxiety level at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire

  7. Change from Baseline depression symptoms at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire

  8. Change from Baseline sleeping habits at 12 weeks [ Time Frame: 12 weeks ]
    Questionnaire

  9. 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.

  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962583


Contacts
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Contact: Angelo Tremblay, Ph.D 418-656-7294 angelo.tremblay@kin.ulaval.ca

Locations
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Canada, Quebec
PEPS - Université Laval Recruiting
Québec, Quebec, Canada, G1V0A6
Contact: Lucie Brunelle, M.Sc.    418-656-2131 ext 6721    lucie.brunelle@kin.ulaval.ca   
Sponsors and Collaborators
Laval University
Lallemand Health Solutions
Investigators
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Study Director: Angelo Tremblay, Ph.D Laval University

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Responsible Party: Angelo Tremblay, Professor, Laval University
ClinicalTrials.gov Identifier: NCT02962583     History of Changes
Other Study ID Numbers: CLIN-21-012
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms