Clinical trial NCT00916175: Metabolic Syndrome and Functional Food
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Keywords: hyperglycemia
overweight
functional food
aloe vera
cnidoscolus chayamansa
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 125
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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%.
timeFrame: baseline, and at the end of each of 2 treatment periods of 4 weeks
Secondary outcomes:
measure: Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.
timeFrame: baseline, and after four weeks of treatment or sooner if needed
measure: Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.
timeFrame: after each week taking the product
Other outcomes:
Locations:
city: Guadalupe
country: Mexico
facility: Fomerrey 19 Community Clinic
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Endocrinology, Outpatient clinic of University Hospital UANL
state: Nuevo Leon
Study officials:
affiliation: Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
name: Lilia Cardenas-Ibarra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
name: Jesus Z Villarreal-Perez, MD
role: STUDY_CHAIR
References: