Metabolic Syndrome and Functional Food
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|ClinicalTrials.gov Identifier: NCT00916175|
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : December 2, 2016
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 or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||October 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||March 2009|
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
Other Name: Placebo 1 and Placebo 2
Food Product P1&CC contains: placebo1 (mimics liquified aloe vera gel) 30ml and Cnidoscolus Chayamansa infusion 200ml;
Dietary Supplement: P1&CC
Other Name: Placebo 1 and Cnidoscolus Chayamansa infusion
Food product AG&P2 contains (liquified aloe vera gel) 30ml and placebo2 (mimic CC infusion) 200ml.
Dietary Supplement: AG&P2
Other Name: Aloe Vera Gel and Placebo 2
Food product AG&CC is composed of: liquified aloe vera gel 30ml and Cnidoscolus Chayamansa infusion 200ml
Dietary Supplement: AG&CC
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)
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
Other Name: Placebo 3
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916175
|Fomerrey 19 Community Clinic|
|Guadalupe, Nuevo Leon, Mexico|
|Endocrinology, Outpatient clinic of University Hospital UANL|
|Monterrey, Nuevo Leon, Mexico, 54460|
|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|