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Completed

NCT Number: NCT00916175

Metabolic Syndrome and Functional Food

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.

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Key information

Conditions

Metabolic Syndrome Body Weight Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Fomerrey 19 Community Clinic, Guadalupe, Nuevo León, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P1&P2

Dietary Supplement
  • 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

Other names: Placebo 1 and Placebo 2

P1&CC

Dietary Supplement
  • 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.

Other names: Placebo 1 and Cnidoscolus Chayamansa infusion

AG&P2

Dietary Supplement
  • 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

Other names: Aloe Vera Gel and Placebo 2

AG&CC

Dietary Supplement
  • 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

Other names: Aloe Vera gel and Cnidoscolus Chayamansa infusion, Sabila & Chaya infusion

TA (concentrated 5:1 aloe vera gel)

Dietary Supplement
  • 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.

Other names: Total Aloe concentrated 5:1 aloe vera gel by total process

P3

Dietary Supplement
  • 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.

Other names: Placebo 3

Primary outcomes

  1. 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%.

    Time frame: baseline, and at the end of each of 2 treatment periods of 4 weeks

Secondary outcomes

  1. Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.

    Time frame: baseline, and after four weeks of treatment or sooner if needed

  2. Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.

    Time frame: after each week taking the product

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 9, 2009
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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