Metabolic Syndrome and Functional Food

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lilia Csrdenas-Ibarra, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier:
NCT00916175
First received: June 8, 2009
Last updated: June 28, 2012
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Dietary Supplement: placebo1 and placebo2
Dietary Supplement: Placebo 2 and CC
Dietary Supplement: Aloe Vera and placebo 1
Dietary Supplement: Aloe Vera and Cnidoscolus Chayamansa
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de Nuevo Leon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 125
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 2 & Placebo 1

Food product with 30ml placebo 2 (placebo aloe vera gel/juice) and 200ml placebo2 (placebo CC infusion):

  • first period (4 weeks) food product (one 230ml lemon gelatin before breakfast) plus 1500 kilocalories diet
  • second period (4 weeks) food product (two 230ml lemon gelatin one before breakfast and other after supper) plus 1500 kilocalories diet
Dietary Supplement: placebo1 and placebo2
30ml liquid resembling aloe vera juice plus 200ml liquid resembling chayamansa infusion
Experimental: Placebo 2 & CC

Product containing 30ml placebo 2 (mimics aloe vera gel/juice) and 200ml of CC infusion:

  • first period (4 weeks) food product (one 230ml lemon gelatin before breakfast) plus 1500 kilocalories diet
  • second period (4 weeks) food product (two 230ml lemon gelatin one before breakfast and other after supper) plus 1500 kilocalories diet
Dietary Supplement: Placebo 2 and CC
Cnidoscolus Chayamansa infusion
Other Name: te of chaya
Experimental: AV & Placebo 1

Food product containing 30ml aloe vera gel/juice and 200ml placebo 1 (placebo CC infusion):

  • first period (4 weeks) food product (one 230ml lemon gelatin before breakfast) plus 1500 kilocalories diet
  • second period (4 weeks) food product (two 230ml lemon gelatin one before breakfast and other after supper) plus 1500 kilocalories diet
Dietary Supplement: Aloe Vera and placebo 1
aloe vera juice and placebo 1
Other Name: Sabila
Experimental: AV and CC

Food product containing 30ml aloe vera gel/juice and 200ml CC infusion:

  • first period (4 weeks) food product(one 230ml lemon gelatin before breakfast) plus 1500 kilocalories diet
  • second period (4 weeks) food product (two 230ml lemon gelatin one before breakfast and other after supper)plus 1500 kilocalories diet
Dietary Supplement: Aloe Vera and Cnidoscolus Chayamansa
aloe vera juice plus Cnidoscolus chayamansa infusion
Other Names:
  • Sabila
  • te of chaya

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916175

Locations
Mexico
Fomerrey 19 Community Clinic
Guadalupe, Nuevo Leon, Mexico
Endocrinology, Outpatient clinic of University Hospital UANL
Monterrey, Nuevo Leon, Mexico, 54460
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
Principal Investigator: Lilia Cardenas-Ibarra, MD Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Study Chair: Jesus Zacarias Villarreal-Perez, MD Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
  More Information

No publications provided

Responsible Party: Lilia Csrdenas-Ibarra, MD, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT00916175     History of Changes
Other Study ID Numbers: EN_LC_P134
Study First Received: June 8, 2009
Last Updated: June 28, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad Autonoma de Nuevo Leon:
hyperglycemia
overweight
functional food
aloe vera
cnidoscolus chayamansa

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014