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| Name | Class |
|---|---|
| Nois de México | OTHER |
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The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.
Investigation of the efficacy of probiotics as adjuvant in the management of overweight and obesity. Specifically, in the reduction of abdominal/visceral adipose tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks. |
|
| Postbiotic | Experimental | Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (Heat treated bacteria) for 16 weeks. |
|
| Placebo | Placebo Comparator | Participants in this arm will receive an equivalent placebo for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal/visceral fat area | Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups. | 0 week to 16 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in abdominal subcutaneous fat area | Difference in abdominal subcutaneous fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups. | 0 week to 16 week |
| Change in body composition |
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Inclusion Criteria:
Male and female subjects from 18 to 65 years old.
Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)
Waist circumference ≥ 102 cm for men
Waist circumference ≥ 88 cm for women
Signature of the informed consent letter.
Agreement to comply with the protocol and study restrictions
Exclusion Criteria:
Diagnosed and pharmacologically-treated type 1 or type 2 diabetes
Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease
Immunosuppression or ongoing therapy causing immunosuppression
Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia
Subjects consuming antibiotics in the previous 2 months
Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
History of chronic active inflammatory disorders
History of bariatric surgery
History of any chronic gastrointestinal disease (e.g. IBD).
Known hypersensitivity to any ingredients in the active or placebo products.
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| Name | Affiliation | Role |
|---|---|---|
| Joshue Covarrubia Esquer, Dr | NOIS DE MEXICO S.A. DE C.V. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nois de Mexico S.A. de C.V. | Guadalajara | 45050 | Mexico |
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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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| Postbiotic | Dietary Supplement | Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain postbiotic (Heat treated bacteria) for 16 weeks. |
|
| Placebo | Dietary Supplement | Participants in this arm will receive an equivalent placebo for 16 weeks. |
|
Difference in total body fat mass (kg) from baseline to 4 months of product intake within and between groups (relative and absolute, measured by bioelectrical impedance at V1 and V4).
| 0 week to 16 week |
| Change in body weight | Body weight change (percent and kg) at all visits - difference within and between groups. | week 0, week 4, week 8, week 16 |
| Change in BMI | BMI change (units and percent) at all visits - difference within and between groups. | week 0, week 4, week 8, week 16 |
| Change in waist circumference | Change in waist circumference (all visits V1-4) | week 0, week 4, week 8, week 16 |
| Change in hip circumference | Change in hip circumference at all visits difference within and between groups (absolute and relative) | week 0, week 4, week 8, week 16 |
| Change in lipid profile | Change in total cholesterol, triglycerides, LDL, VLDL and HDL (mg/dL) (baseline and 4 months) | week 0, week 16 |
| Change in systolic and diastolic blood pressure | Change in systolic and diastolic blood pressure (mmHg) | week 0, week 4, week 8, week 16 |
| Changes in glucose profile | Change in HOMA-IR (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5) | week 0, week 16 |
| Change in cortisol levels | Change in cortisol levels (nmol/L) | week 0, week 16 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |