Metabolic Syndrome and Functional Food

Summary

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.

Conditions

• Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

P1&P2

* 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

DIETARY_SUPPLEMENT

P1&CC

* 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.

DIETARY_SUPPLEMENT

AG&P2

* 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

DIETARY_SUPPLEMENT

AG&CC

* 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

DIETARY_SUPPLEMENT

TA (concentrated 5:1 aloe vera gel)

* 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.

DIETARY_SUPPLEMENT

P3

* 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon

  lead OTHER

Principal Investigators

• Lilia Cardenas-Ibarra, MD · Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon

• Jesus Z Villarreal-Perez, MD · Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-10-31

Primary Completion

2008-12-31

Completion

2009-03-31

Countries

• Mexico

Study Locations