Metabolic Syndrome and Functional Food

Universidad Autonoma de Nuevo Leon

Status and phase: Completed; Phase 3; Phase 2

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: P3; Dietary Supplement: P1&CC; Dietary Supplement: TA (concentrated 5:1 aloe vera gel); Dietary Supplement: P1&P2; Dietary Supplement: AG&CC; Dietary Supplement: AG&P2

Study type: Interventional

Funder types: Other

Identifiers

NCT00916175

EN_LC_P134

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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125 participants in 6 patient groups, including a placebo group

P1&P2

Placebo Comparator group

Description:

Food product P1\&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml;

Treatment:

Dietary Supplement: P1&P2

P1&CC

Experimental group

Description:

Food Product P1\&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml;

Treatment:

Dietary Supplement: P1&CC

AG&P2

Experimental group

Description:

Food product AG\&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml.

Treatment:

Dietary Supplement: AG&P2

AG&CC

Experimental group

Description:

Food product AG\&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml

Treatment:

Dietary Supplement: AG&CC

TA (concentrated 5:1 aloe vera gel)

Experimental group

Description:

Food product TA contains concentrated 5:1 aloe vera gel by total process30 ml and purified water 200 ml.

Treatment:

Dietary Supplement: TA (concentrated 5:1 aloe vera gel)

P3

Placebo Comparator group

Description:

Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml.

Treatment:

Dietary Supplement: P3