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

This is an interventional treatment trial for Obesity Read More

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.