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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebos; Other: Weight loss; Drug: Probiotic Formula

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V0A6
      • PEPS - Université Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; Daily probiotic consumption	Other: Weight loss; Drug: Probiotic Formula
Placebo Comparator: Placebo; Daily placebo consumption	Drug: Placebos; Other: Weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline body weight at 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	DXA	12 weeks
Change from Baseline stress level at 12 weeks	Questionnaire	12 weeks
Change from Baseline anxiety level at 12 weeks	Questionnaire	12 weeks
Change from Baseline depression symptoms at 12 weeks	Questionnaire	12 weeks
Change from Baseline sleeping habits at 12 weeks	Questionnaire	12 weeks
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.	12 weeks
Change from Baseline C-reactive protein at 12 weeks		12 weeks
Change from Baseline TNF-a at 12 weeks		12 weeks
Change from Baseline interleukin-6 at 12 weeks		12 weeks
Change from Baseline lipopolysaccharide (LPS) at 12 weeks		12 weeks

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Lallemand Health Solutions
• Investigators: Study Director: Angelo Tremblay, Ph.D, Laval University

Publications and helpful links

General 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. 2022 Jun 17:1-13. doi: 10.1080/1028415X.2022.2081288. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: CLIN-21-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO