A Phase 2 interventional study of Weight loss and Probiotic Formula in Obesity, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by Laval University · Phase 2, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 152 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
Daily probiotic consumption
Other: Weight loss · Drug: Probiotic Formula
Daily placebo consumption
Other: Weight loss · Drug: Placebos
Change from Baseline body weight at 12 weeks
Time frame: 12 weeks
Change from Baseline BMI at 12 weeks
Time frame: 12 weeks
Change from Baseline waist circumference data at 12 weeks
Time frame: 12 weeks
Change from Baseline sagittal abdominal diameter data at 12 weeks
Time frame: 12 weeks
Change from Baseline body composition at 12 weeks
DXA
Time frame: 12 weeks
Change from Baseline stress level at 12 weeks
Questionnaire
Time frame: 12 weeks
Change from Baseline anxiety level at 12 weeks
Questionnaire
Time frame: 12 weeks
Change from Baseline depression symptoms at 12 weeks
Questionnaire
Time frame: 12 weeks
Change from Baseline sleeping habits at 12 weeks
Questionnaire
Time frame: 12 weeks
Change from Baseline intestinal microbiota composition at 12 weeks
Changes in the concentrations of the probiotic strains in the stools will be measured with strain specific DNA in fecal samples.
Time frame: 12 weeks
Change from Baseline C-reactive protein at 12 weeks
Time frame: 12 weeks
Change from Baseline TNF-a at 12 weeks
Time frame: 12 weeks
Change from Baseline interleukin-6 at 12 weeks
Time frame: 12 weeks
Change from Baseline lipopolysaccharide (LPS) at 12 weeks
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Laval University