Metabolic Syndrome and Functional Food

Universidad Autonoma de Nuevo Leon125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

125

Conditions

Metabolic Syndrome

Interventions

* First period (4 weeks) intake food product P1\&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet * Second period, cross over from AG\&CC group, 4 weeks intake food product P1\&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet

P1&CCDIETARY_SUPPLEMENT

* First period (4 weeks) intake food product P1\&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from AG\&P2 group, 4 weeks intake food product P1\&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.

AG&P2DIETARY_SUPPLEMENT

* First period (4 weeks) intake food product AG\&P2 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from P1\&CC group, 4 weeks intake food product AG\&P2 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet

AG&CCDIETARY_SUPPLEMENT

* First period (4 weeks) intake food product AG\&CC (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet * Second period, cross over from P1\&P2 group, 4 weeks intake food product AG\&CC (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet

TA (concentrated 5:1 aloe vera gel)DIETARY_SUPPLEMENT

* First period (4 weeks) intake food product TA (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from P3 group, 4 weeks intake food product TA (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.

P3DIETARY_SUPPLEMENT

* First period (4 weeks) intake food product P3 (in lemon gelatin 230 ml before breakfast) plus 1500 kilo calories diet. * Second period, cross over from TA group, 4 weeks intake food product P3 (in lemon gelatin 230 ml before breakfast and 230 ml after supper) plus 1500 kilo calories diet.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion criteria: * Adult women living in Monterrey, Mexico with at least three of the following: * waist line equal or larger than 88 cm * fasting blood sugar between 100-140 mg/dL without symptoms or known glucose intolerance or diabetes treated only with diet * known high blood pressure or 2/3 readings systolic \> 130 mmHg, diastolic \> 85 * HLD \< 50 mg/dL or triglycerides \> 150 mg/dL Exclusion Criteria: * Pregnancy or nursing * On anti-diabetic agents * Diabetic symptoms or advanced DM complications * Severe behavioral problems

Locations (2)

Fomerrey 19 Community Clinic

Guadalupe, Nuevo León, Mexico

Endocrinology, Outpatient clinic of University Hospital UANL

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

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%.

Time frame: baseline, and at the end of each of 2 treatment periods of 4 weeks

Secondary Outcomes

Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.

Time frame: 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.

Time frame: after each week taking the product