| Trial ID: | L6446 |
| Source ID: | NCT01377961
|
| Associated Drug: |
Randomized Pills Either Containing Combination Of Lycopene And Isoflavones (Dietary Supplements) Or Placebo To Be Taken For 12 Weeks
|
| Title: |
Effect of Lycopene and Isoflavones on Glucose Metabolism
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Metabolic Syndrome|Diabetes Mellitus, Non-Insulin-Dependent
|
| Interventions: |
DRUG: Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks|OTHER: Screening|OTHER: OGTT|OTHER: Anthropometrics and Blood pressure|OTHER: Screening|OTHER: Blood Drawing
|
| Outcome Measures: |
Primary: Insulin Resistance, For Arm 1:Assessment of the Changes in the insulin resistance from baseline to 12 weeks., 12 weeks|A1C, For Arm 2:Assessment of the Changes in the A1C from baseline to 12 weeks., 12 weeks | Secondary: For Arm 1 :AUCglucose, For Arm 1: Changes of AUCglucose from baseline to 12 weeks., 12 weeks|For Arm1 and Arm 2: The secondary outcome measure are Plasma Lipids concentrations, For Arm 2: Changes in the Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones, EPCs count and function, Chlamydia Trachomatis titers in serum from baseline to 12 weeks., 12 weeks|For Arm 1 :AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones concentration,EPCs count and function,Chlamydia Trachomatis titers in serum, For Arm 1: Changes of AUCglucose,Plasma Lipids concentrations,BMI,Plasma lycopene and isoflavones,EPCs count and function,Chlamydia Trachomatis titers in serum from baseline to 12 weeks., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Medical Branch, Galveston
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-09
|
| Completion Date: |
2015-08
|
| Results First Posted: |
|
| Last Update Posted: |
2015-06-26
|
| Locations: |
Internal Medicine, Galveston, Texas, 77550, United States|Stark Diabetes Center Clinic, Galveston, Texas, 77550, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01377961
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