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| Name | Class |
|---|---|
| Société des Produits Nestlé (SPN) | INDUSTRY |
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Probiotics administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotics consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009) as well as abdominal fat in human (Kadooka Y, 2010). The mechanisms explaining the effects of probiotics in weight control are not well understood.
The primary objective of the clinical trial is to investigate whether a consumption of a probiotic formula when compared to an intake of a placebo, is associated with a greater reduction of body weight.
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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 |
|---|---|---|---|---|
| Probiotic | Other | daily probiotic consumption |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight; Body composition (DEXA); Waist circumference | PRE and POST |
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Inclusion Criteria:
Exclusion Criteria:
Under antibiotics or treatments (medication or nutritional program) affecting body weight or glucose control for the last 3 months
Currently participating or having participated in another clinical trial during the last 6 months prior to the beginning of this study
Pregnant women, women who have given birth in the past year, women planning pregnancy in the next 6 months or menopausal women
Excessive consumption of products enriched in probiotics (> 4 servings per week).
History of drug or alcohol (> 2 drinks daily) abuse
Abnormal thyroid hormone levels
Intake of medication that could affect body weight and/or energy expenditure
Family history of type 2 diabetes in first degree relatives
Allergy to the ingredients in the study product and placebo
Participant with anaemia
Participant with a recent history of large weight fluctuations (e.g., > 10 kg in the past year
Immune-compromised conditions
Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain
Participant with co-morbidity associated with obesity:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University and Laval Hospital | Québec | Quebec | G1V 0A6 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Other |
daily placebo consumption |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |