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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
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There is evidence that genistein present in soy can improve insulin resistance in rodents and humans with metabolic syndrome (MetS). However, it is not known if this improvement is associated with changes in the gut microbiota. In the present study, the investigators show that the consumption of genistein for 2 months could have an effect on insulin resistance in subjects with MetS. This effect will be accompanied by a modification of the gut microbiota taxonomy. As a consequence, there will be a reduction in metabolic endotoxemia accompanied by an increase in AMP-activated protein kinase (AMPK) phosphorylation and the expression of genes of fatty acid oxidation in skeletal muscle.
The investigators included 45 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of MetS, HOMA index greater than 2.5, BMI ≥30 and ≤ 40 kg / m2 and who signed the consent letter. Patients who had any added pathology, pregnancy, smoking or consumed medications were excluded. Once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. These individuals were advised to consume the recommended diet for subjects with MetS according to the guidelines of the ATPIII. Participants were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months. In the previsit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile, lipopolysaccharide and serum insulin. Also determined blood pressure, body weight, height, body composition and gut microbiota. The presence of insulin resistance was determined by means of the HOMA-IR index and by an oral glucose tolerance test. After 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then RNA extraction and gene expression microarray assay was performed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| genistein | Experimental | Genistein capsules of 25 mg each, 50mg/day |
|
| placebo | Placebo Comparator | Maltodextrin capsules, administered orally once every 12 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genistein | Dietary Supplement | Administered orally once every 12 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| intestinal microbiota | Measurement of gut microbiota by sequencing using the Illumina platform | Baseline to 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| glucose metabolism profile | serum glucose (mg/dL) | Baseline to 2 month |
| Glucose metabolism profile | serum insulin (µUI/ml) | Baseline to 2 month |
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Inclusion Criteria:
Exclusion Criteria:
• Patients with any type of diabetes.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31451009 | Background | Guevara-Cruz M, Flores-Lopez AG, Aguilar-Lopez M, Sanchez-Tapia M, Medina-Vera I, Diaz D, Tovar AR, Torres N. Improvement of Lipoprotein Profile and Metabolic Endotoxemia by a Lifestyle Intervention That Modifies the Gut Microbiota in Subjects With Metabolic Syndrome. J Am Heart Assoc. 2019 Sep 3;8(17):e012401. doi: 10.1161/JAHA.119.012401. Epub 2019 Aug 27. | |
| 31030168 |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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These individuals were advised to consume the recommended diet for subjects with MetS according to the guidelines of the ATPIII. Patients were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). The participants were followed for 2 months
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The interventions with genistein and placebo were identically encapsulated in appearance, both the researcher and the participant did not know what type of maneuver was assigned. The bottle with the capsules was distributed by a person outside the study who was the same one who performed the randomization.
Study staff and participants were blinded during the assignment and execution of the interventions in the study. the capsules delivered to the participants were 2 per day, the capsules had the same color and appearance
| Placebo |
| Dietary Supplement |
Administered orally once every 12 hours |
|
| Triglycerides | serum triglycerides (mg/dL) | Baseline to 2 month |
| Total Cholesterol | serum total cholesterol (mg/dL) | Baseline to 2 month |
| LDL cholesterol | serum LDL cholesterol (mg/dL) | Baseline to 2 month |
| HDL cholesterol | serum HDL cholesterol (mg/dL) | Baseline to 2 month |
| Inflammatory profile | plasma lipopolysaccharide (LPS) (ng/mL) | Baseline to 2 month |
| Body weight | body weight (kg) | Baseline to 2 month |
| Blood pressure | blood pressure (mmHg) | Baseline to 2 month |
| Palacios-Gonzalez B, Vargas-Castillo A, Velazquez-Villegas LA, Vasquez-Reyes S, Lopez P, Noriega LG, Aleman G, Tovar-Palacio C, Torre-Villalvazo I, Yang LJ, Zarain-Herzberg A, Torres N, Tovar AR. Genistein increases the thermogenic program of subcutaneous WAT and increases energy expenditure in mice. J Nutr Biochem. 2019 Jun;68:59-68. doi: 10.1016/j.jnutbio.2019.03.012. Epub 2019 Mar 29. |
| 29979819 | Background | Lopez P, Sanchez M, Perez-Cruz C, Velazquez-Villegas LA, Syeda T, Aguilar-Lopez M, Rocha-Viggiano AK, Del Carmen Silva-Lucero M, Torre-Villalvazo I, Noriega LG, Torres N, Tovar AR. Long-Term Genistein Consumption Modifies Gut Microbiota, Improving Glucose Metabolism, Metabolic Endotoxemia, and Cognitive Function in Mice Fed a High-Fat Diet. Mol Nutr Food Res. 2018 Aug;62(16):e1800313. doi: 10.1002/mnfr.201800313. Epub 2018 Jul 29. |
| 30266575 | Background | Medina-Vera I, Sanchez-Tapia M, Noriega-Lopez L, Granados-Portillo O, Guevara-Cruz M, Flores-Lopez A, Avila-Nava A, Fernandez ML, Tovar AR, Torres N. A dietary intervention with functional foods reduces metabolic endotoxaemia and attenuates biochemical abnormalities by modifying faecal microbiota in people with type 2 diabetes. Diabetes Metab. 2019 Apr;45(2):122-131. doi: 10.1016/j.diabet.2018.09.004. Epub 2018 Sep 25. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |