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Metabolic Syndrome and Functional Food

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
P1&P2
P1&CC
AG&P2
AG&CC
TA (concentrated 5:1 aloe vera gel)
P3
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring hyperglycemia, overweight, functional food, aloe vera, cnidoscolus chayamansa

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Fomerrey 19 Community Clinic
  • Endocrinology, Outpatient clinic of University Hospital UANL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

P1&P2

P1&CC

AG&P2

AG&CC

TA (concentrated 5:1 aloe vera gel)

P3

Arm Description

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

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

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

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

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

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

Outcomes

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%.

Secondary Outcome Measures

Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.
Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.

Full Information

First Posted
June 8, 2009
Last Updated
December 1, 2016
Sponsor
Universidad Autonoma de Nuevo Leon
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1. Study Identification

Unique Protocol Identification Number
NCT00916175
Brief Title
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

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
hyperglycemia, overweight, functional food, aloe vera, cnidoscolus chayamansa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P1&P2
Arm Type
Placebo Comparator
Arm Description
Food product P1&P2 is composed of: placebo1(mimic aloe vera gel) 30ml and placebo2 (mimic Cnidoscolus chayamansa infusion) 200ml;
Arm Title
P1&CC
Arm Type
Experimental
Arm Description
Food Product P1&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml;
Arm Title
AG&P2
Arm Type
Experimental
Arm Description
Food product AG&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml.
Arm Title
AG&CC
Arm Type
Experimental
Arm Description
Food product AG&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml
Arm Title
TA (concentrated 5:1 aloe vera gel)
Arm Type
Experimental
Arm Description
Food product TA contains concentrated 5:1 aloe vera gel by total process30 ml and purified water 200 ml.
Arm Title
P3
Arm Type
Placebo Comparator
Arm Description
Food product Placebo 3 contains stabilizers and preservative used for TA 30 ml and purified water 200 ml.
Intervention Type
Dietary Supplement
Intervention Name(s)
P1&P2
Other Intervention Name(s)
Placebo 1 and Placebo 2
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
P1&CC
Other Intervention Name(s)
Placebo 1 and Cnidoscolus Chayamansa infusion
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AG&P2
Other Intervention Name(s)
Aloe Vera Gel and Placebo 2
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
AG&CC
Other Intervention Name(s)
Aloe Vera gel and Cnidoscolus Chayamansa infusion, Sabila & Chaya infusion
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
TA (concentrated 5:1 aloe vera gel)
Other Intervention Name(s)
Total Aloe concentrated 5:1 aloe vera gel by total process
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
P3
Other Intervention Name(s)
Placebo 3
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilia Cardenas-Ibarra, MD
Organizational Affiliation
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesus Z Villarreal-Perez, MD
Organizational Affiliation
Endocrinology, University Hospital, Universidad Autonoma de Nuevo Leon
Official's Role
Study Chair
Facility Information:
Facility Name
Fomerrey 19 Community Clinic
City
Guadalupe
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Endocrinology, Outpatient clinic of University Hospital UANL
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
54460
Country
Mexico

12. IPD Sharing Statement

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Metabolic Syndrome and Functional Food

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