NCT00916175

Metabolic Syndrome and Functional Food

Randomized Double Blind Factorial Assay, Aloe Vera (AV) And/Or Cnidoscolus Chayamansa (CC) Versus Placebo, Reduction Of High Blood Glucose In Women With Metabolic Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Universidad Autonoma de Nuevo Leon · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2008-12-01
• Completion: 2009-03-01
• First posted: 2009-06-09
• Last updated: 2016-12-02

Locations

2 sites across 1 country: Mexico