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High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV) and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on blood glucose and body weight.
The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high blood sugar in adult women with pre-diabetes (Metabolic Syndrome).
Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2, at the outpatient clinic of the university Hospital and a community clinic.
Two treatment periods of 4 weeks intermediated by one week for wash-out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P1&P2 | Placebo Comparator | Food product P1&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml; |
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| P1&CC | Experimental | Food Product P1&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml; |
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| AG&P2 | Experimental | Food product AG&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml. |
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| AG&CC | Experimental | Food product AG&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml |
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| TA (concentrated 5:1 aloe vera gel) | Experimental | Food product TA contains concentrated 5:1 aloe vera gel by total process30 ml and purified water 200 ml. |
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| P3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P1&P2 | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction of elevated blood sugar (HbA1c) by Immunoturbidimetric test (One-HbA1c FS) via Star-Dust MC15; both from Diagnostic systems international (DiaSys); its coefficient of variation was 1.6%. | baseline, and at the end of each of 2 treatment periods of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported. | baseline, and after four weeks of treatment or sooner if needed | |
| Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints. |
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Inclusion criteria:
Adult women living in Monterrey, Mexico with at least three of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilia Cardenas-Ibarra, MD | Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon | Principal Investigator |
| Jesus Z Villarreal-Perez, MD | Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fomerrey 19 Community Clinic | Guadalupe | Nuevo León | Mexico | |||
| Endocrinology, Outpatient clinic of University Hospital UANL |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2017 | |
| Reset | Apr 26, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2017 | Apr 26, 2017 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C586178 | Aloe vera gel |
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| Placebo Comparator |
Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml. |
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| P1&CC | Dietary Supplement |
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| AG&P2 | Dietary Supplement |
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| AG&CC | Dietary Supplement |
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| TA (concentrated 5:1 aloe vera gel) | Dietary Supplement |
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| P3 | Dietary Supplement |
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| after each week taking the product |
| Monterrey |
| Nuevo León |
| 54460 |
| Mexico |
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |