Obesity Clinical Trial
Official title:
Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals
Verified date | April 2021 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 30 |
Est. completion date | January 31, 2018 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Richardson Centre for Functional Foods and Nutraceuticals | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Lallemand Health Solutions |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body weight | 60 days | ||
Secondary | Body mass index | 60 days | ||
Secondary | Body fat percentage | 60 days | ||
Secondary | Waist circumference | 60 days | ||
Secondary | Hip circumference | 60 days | ||
Secondary | Total fat mass | 60 days | ||
Secondary | Total lean mass | 60 days | ||
Secondary | Gut microbiome | Stool samples will be collected from participants to analyze intestinal microbiota community composition | 60 days | |
Secondary | Blood pressure | 60 days | ||
Secondary | Blood total cholesterol | 60 days | ||
Secondary | Blood low-density lipoprotein cholesterol | 60 days | ||
Secondary | Blood high-density lipoprotein cholesterol | 60 days | ||
Secondary | Blood triglycerides | 60 days | ||
Secondary | Blood glucose | 60 days | ||
Secondary | Blood insulin | 60 days | ||
Secondary | Aspartate aminotransferase | 60 days | ||
Secondary | Alanine transaminase | 60 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |