Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals

The aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. In addition, a diet supplemented with probiotics can be expected to be more beneficial than a diet without probiotic supplementation in impacting biomarkers of obesity-associated disorders including diabetes, hypertension and cardiovascular disease (CVD).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotics

Detailed Description

Overweight, obese men and women volunteers aged between 18-65 yrs with BMI greater than or equal to 25 will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized, double-blind, placebo-controlled, free-living intervention study for 60 days per study period following obtainment of informed consent. Participants will be informed to maintain their usual diets as well as their physical activity level.

After obtaining consent, participants will be randomized to receive either 1 capsule containing probiotics, or 1 capsule of placebo daily for 60 days. Compared with the probiotic capsules, the placebo contains the same carrier material and is similar in size, shape and taste.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Centre for Functional Foods and Nutraceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overweight, obese men and women volunteers aged between 18-65 yrs
• BMI equal to or greater than 25
• Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
• Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substances for control body weight.
• Able to provide informed consent.
• Women of childbearing potential with a negative pregnancy test at screening.

Exclusion Criteria

• BMI greater than 35
• Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
• Those currently taking (or have taken within the last 3 months) cholesterol-lowering, triglyceride-lowering or hypertension medications.
• Those currently taking (or have taken within the last 3 months) lipid-lowering supplements, (e.g., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc).
• Smokers.
• Allergic to milk, soy, or yeast (some of our probiotics strains may contains these items).
• Use of another investigational product within 3 months of the screening visit.
• Positive pregnancy test in women of child-bearing potential.
• 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.
• Use of any other treatments (medication or nutritional program) affecting body weight, food intake and/or energy expenditure.
• Menopausal women.
• Weight gain or loss of at least 10lbs in previous three months.
• Uncontrolled angina within the past six months.
• 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 HIV/AIDS).
• 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.
• History of drug or alcohol (> 2 drinks daily) abuse.
• Abnormal thyroid hormone levels.
• Immune-compromised conditions.
• Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain (past week and chronic).
• Participants exercising > 15 miles/wk or 4,000 kcal/wk.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; 1 capsule per day containing probiotics	Dietary supplement: Probiotics
Placebo Comparator: Placebo; 1 capsule per day without probiotics	Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body weight	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index		60 days
Body fat percentage		60 days
Waist circumference		60 days
Hip circumference		60 days
Total fat mass		60 days
Total lean mass		60 days
Gut microbiome	Stool samples will be collected from participants to analyze intestinal microbiota community composition	60 days
Blood pressure		60 days
Blood total cholesterol		60 days
Blood low-density lipoprotein cholesterol		60 days
Blood high-density lipoprotein cholesterol		60 days
Blood triglycerides		60 days
Blood glucose		60 days
Blood insulin		60 days
Aspartate aminotransferase		60 days
Alanine transaminase		60 days

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Lallemand Health Solutions

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: September 2, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: B2016:033