Metabolic Syndrome and Functional Food

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916175
• Other study ID #: EN_LC_P134
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 8, 2009
• Last updated: December 1, 2016
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2009
• Source: Universidad Autonoma de Nuevo Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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
• 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.
• 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
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Mexico	Fomerrey 19 Community Clinic	Guadalupe	Nuevo Leon
Mexico	Endocrinology, Outpatient clinic of University Hospital UANL	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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