Metabolic Syndrome and Functional Food

Phase 2

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: AG&CC; Dietary Supplement: P3; Dietary Supplement: AG&P2; Dietary Supplement: P1&P2; Dietary Supplement: P1&CC

• Registration Number: NCT00916175
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Status Verified: 2009-07
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

• Pregnancy or nursing
• On anti-diabetic agents
• Diabetic symptoms or advanced DM complications
• Severe behavioral problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AG&CC	AG&CC	Food product AG\&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml
P3	P3	Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml.
AG&P2	AG&P2	Food product AG\&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml.
P1&P2	P1&P2	Food product P1\&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml;
P1&CC	P1&CC	Food Product P1\&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml;

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.	after each week taking the product
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

Trial Locations

Locations (2)

Fomerrey 19 Community Clinic; 🇲🇽 Guadalupe, Nuevo Leon, Mexico

Endocrinology, Outpatient clinic of University Hospital UANL; 🇲🇽 Monterrey, Nuevo Leon, Mexico