Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129792
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2005-08-10
Brief Title:
Education Counseling and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Expectancy Self-Efficacy and Outcomes in Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effects of a supplement in reducing symptoms of metabolic syndrome a collection of symptoms that increase the risk for developing heart disease stroke and diabetes
Detailed Description:
Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and obesity these symptoms are associated with a two- to fourfold increased risk for cardiovascular disease and diabetes The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger increasing energy and improving insulin function
This study will last 12 weeks Participants will be randomly assigned to one of three arms Participants in Arm 1 will receive the supplement participants in Arm 2 will have a 50 chance of receiving either the supplement or placebo participants in Arm 3 will receive placebo Participants will take their assigned pills 3 times daily for 12 weeks A follow-up visit will occur at the end of the 12 weeks there will be a debriefing visit shortly after the follow-up visit Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose insulin cholesterol and levels of certain hormones Participants will also be asked to complete questionnaires at study entry and at Week 12 the questionnaires will assess depression stress self-absorption optimism food cravings hunger the degree to which participants seek pleasure from activities and participants thoughts about their ability to make behavioral changes
This study will last 12 weeks Participants will be randomly assigned to one of three arms Participants in Arm 1 will receive the supplement participants in Arm 2 will have a 50 chance of receiving either the supplement or placebo participants in Arm 3 will receive placebo Participants will take their assigned pills 3 times daily for 12 weeks A follow-up visit will occur at the end of the 12 weeks there will be a debriefing visit shortly after the follow-up visit Participants in all 3 arms will receive weekly education and counseling sessions on healthy lifestyle changes to encourage weight loss Blood collection will occur at study start and at the end of 12 weeks for assessment of fasting blood glucose insulin cholesterol and levels of certain hormones Participants will also be asked to complete questionnaires at study entry and at Week 12 the questionnaires will assess depression stress self-absorption optimism food cravings hunger the degree to which participants seek pleasure from activities and participants thoughts about their ability to make behavioral changes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U19AT002656 | NIH | None | httpsreporternihgovquickSearchU19AT002656 |
| U19AT002656-03 | NIH | None | None |
| U19AT002656-02 | NIH | None | None |