Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03728127
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2018-10-29
Brief Title:
Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction
Sponsor:
Hospital do Coracao
Organization:
Hospital do Coracao
Study Overview
Official Title:
Effect of the Brazilian Cardioprotective Diet and Nuts on Cardiometabolic Parameters in Post-acute Myocardial Infarction a Randomized Clinical Trial DICA-NUTS Study
Status:
COMPLETED
Status Verified Date:
2022-02
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:
DICA-NUTS
Brief Summary:
Coronary artery disease CAD is the leading cause of death worldwide Dietary patterns and functional foods may play an important role in the management of cardiovascular risk factors such as overweight and dyslipidemia as well as inflammation and oxidative stress However little is known regarding the effect of diets or specific nutrients on these parameters in individuals with acute myocardial infarction AMI The Brazilian Cardioprotective Diet DicaBr is based on Brazilian nutritional guidelines and also in a unique and ludic nutritional strategy In a pilot study this diet was effective in reducing blood pressure intragroup comparison and body weight intergroup comparison in individuals with established cardiovascular disease CVD However the effectiveness of this dietary pattern supplemented with different kind of nuts is unknown The aim of this study is to evaluate the effect of the DicaBr supplemented or not with 30gday of different nuts on cardiometabolic parameters in patients with recent AMI In this parallel randomized controlled trial 388 patients 40 years with a recent diagnosis of AMI 60 to 180 days will be allocated to one of two study groups 1 DicaBr group DCB control group or 2 DicaBr group supplemented with mixed nuts DCBN intervention group All patients will receive the same dietary prescription the DCBN group also will receive 30gday of nuts 10g of peanuts 10g of cashew nuts and 10g of Brazilian nuts A pilot study including 100 individuals who will receive only peanuts 30gday will be conducted The primary outcome will be LDL-cholesterol LDL-c levels after 16 weeks In the baseline and at the end of the study 16 weeks lipid and glycemic profile and anthropometric indexes will be evaluated in both groups inflammatory and oxidative stress markers and adipokines will be evaluated in a subsample It is expected that DicaBr supplemented with nuts will be superior to DicaBr alone to benefit patients with AMI regarding cardiometabolic parameters
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| U1111-1259-8105 | OTHER | Universal Trial Number - World Health Organization UTN-WHO | None |