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

Study Overview
=================
Brief Summary
-----------------
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).

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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br>1 capsule per day containing probiotics | Dietary Supplement: Probiotics<br> <br> |
| Placebo Comparator: Placebo<br>1 capsule per day without probiotics | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |