Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405197
Status:
COMPLETED
Last Update Posted:
2007-12-12
First Post:
2006-11-28
Brief Title:
MARIS Study Mediterranean Approach to Reduce Insulin-Resistance Study
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
Study on the Effect of Mono-Unsaturated Fatty Acids MUFA and the Mediterranean Diet on Hyperinsulinemia and Other Components of the Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Background During the 1990s the prevalence of the metabolic syndrome in the Netherlands ranged from 3 in women of 20-39 yrs to at least 33 in men 55 yrs and older and it is expected to increasing Prevention is therefore warranted In this respect the amount and type of fat in the diet deserves attention Recently an intervention study reported that a diet high in mono-unsaturated fatty acids MUFA such as from olive oil increased insulin sensitivity in healthy subjects However additional beneficial effects can be expected from the Mediterranean diet as a whole Hypothesis Replacing saturated fatty acids SFA by mono-unsaturated fatty acids MUFA will improve hyperinsulinemia and dyslipidemia and a typical Mediterranean diet will even have more pronounced effects Study objectives To investigate the impact of the Mediterranean diet and especially the intake of MUFA on markers of the metabolic syndrome in high-risk subjects Methods The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10 Expected results Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome
Detailed Description:
None
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