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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: December 1, 2016
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: P1&P2
Dietary Supplement: P1&CC
Dietary Supplement: AG&P2
Dietary Supplement: AG&CC
Dietary Supplement: TA (concentrated 5:1 aloe vera gel)
Dietary Supplement: P3
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: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P1&P2
Food product P1&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml;
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
Other Name: Placebo 1 and Placebo 2
Experimental: P1&CC
Food Product P1&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml;
Dietary Supplement: 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.
Other Name: Placebo 1 and Cnidoscolus Chayamansa infusion
Experimental: AG&P2
Food product AG&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml.
Dietary Supplement: 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
Other Name: Aloe Vera Gel and Placebo 2
Experimental: AG&CC
Food product AG&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml
Dietary Supplement: 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
Other Names:
  • Aloe Vera gel and Cnidoscolus Chayamansa infusion
  • Sabila & Chaya infusion
Experimental: TA (concentrated 5:1 aloe vera gel)
Food product TA contains concentrated 5:1 aloe vera gel by total process30 ml and purified water 200 ml.
Dietary Supplement: 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.
Other Name: Total Aloe concentrated 5:1 aloe vera gel by total process
Placebo Comparator: P3
Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml.
Dietary Supplement: 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.
Other Name: Placebo 3

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
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 Z Villarreal-Perez, MD Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
  More Information

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: December 1, 2016
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:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on December 08, 2016