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About
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.
Enrollment
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Volunteers
Inclusion criteria
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.
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
Primary purpose
Allocation
Interventional model
Masking
152 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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