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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Daily probiotic consumption |
|
| Placebo | Placebo Comparator | Daily placebo consumption |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss | Other |
| ||
| Probiotic Formula |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline body weight at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline BMI at 12 weeks | 12 weeks | |
| Change from Baseline waist circumference data at 12 weeks | 12 weeks | |
| Change from Baseline sagittal abdominal diameter data at 12 weeks |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Angelo Tremblay, Ph.D | Laval University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PEPS - Université Laval | Québec | Quebec | G1V0A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35714163 | Derived | Choi BS, Brunelle L, Pilon G, Cautela BG, Tompkins TA, Drapeau V, Marette A, Tremblay A. Lacticaseibacillus rhamnosus HA-114 improves eating behaviors and mood-related factors in adults with overweight during weight loss: a randomized controlled trial. Nutr Neurosci. 2023 Jul;26(7):667-679. doi: 10.1080/1028415X.2022.2081288. Epub 2022 Jun 17. |
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|
| Placebos | Drug |
|
| 12 weeks |
| Change from Baseline body composition at 12 weeks | DXA | 12 weeks |
| Change from Baseline stress level at 12 weeks | Questionnaire | 12 weeks |
| Change from Baseline anxiety level at 12 weeks | Questionnaire | 12 weeks |
| Change from Baseline depression symptoms at 12 weeks | Questionnaire | 12 weeks |
| Change from Baseline sleeping habits at 12 weeks | Questionnaire | 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. | 12 weeks |
| Change from Baseline C-reactive protein at 12 weeks | 12 weeks |
| Change from Baseline TNF-a at 12 weeks | 12 weeks |
| Change from Baseline interleukin-6 at 12 weeks | 12 weeks |
| Change from Baseline lipopolysaccharide (LPS) at 12 weeks | 12 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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