| Trial ID: | L4435 |
| Source ID: | NCT00699413
|
| Associated Drug: |
Nutrition Education Plus Active Supplement
|
| Title: |
Supplements for Controlling Resistance to Insulin
|
| Acronym: |
SCORE
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00699413/results
|
| Conditions: |
Obesity|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: nutrition education plus active supplement|DRUG: nutrition education plus inactive supplement
|
| Outcome Measures: |
Primary: Body Mass Index, Change in Body Mass Index measurement at baseline and 12 weeks, measured at baseline and 12 weeks | Secondary: Insulin Activity, Change in insulin activity measured at baseline and 12 weeks, Measured at baseline and 12 weeks|Percent Body Fat, Change in percent body fat measured at baseline and 12 weeks, Measured at baseline and 12 weeks|Hunger, Change in hunger score using Likert scale measured at baseline and 12 weeks, Measured at baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Southern California | Collaborators: InterHealth Nutraceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE4
|
| Enrollment: |
8
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2008-02
|
| Completion Date: |
2008-08
|
| Results First Posted: |
2017-05-11
|
| Last Update Posted: |
2024-06-11
|
| Locations: |
USC - Preventive Medicine, Los Angeles, California, 90033, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00699413
|
