Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

Coronary Artery Disease Clinical Trial

— DICA-NUTS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728127
• Other study ID #: DICA-NUTS
• Secondary ID: U1111-1259-8105
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 30g/day 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 30g/day 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 (30g/day) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: December 31, 2022
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria: Patients = 40 years with previous AMI (60 to 180 days).

Exclusion Criteria:

• Clinical indication of myocardial revascularization surgery (graf /bypass);
• HIV positive in treatment/AIDS;
• Chronic inflammatory diseases;
• Cancer;
• Chemical dependency/alcoholism;
• Chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs;
• Pregnancy or lactation;
• Wheelchair users without conditions of anthropometric evaluation;
• Extreme obesity (BMI =40kg / m²);
• Use of dietary supplements;
• Rejection/allergy to oilseed consumption;
• Participation in other randomized studies at the time of enrollment.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Dietary Supplement:
• Brazilian cardioprotective diet
Brazilian cardioprotective diet prescription
• Brazilian cardioprotective diet plus 30g/day of mixed nuts
Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas da Universidade Federal do Paraná (HC-UFPR)	Curitiba
Brazil	Hospital de Clínicas da Universidade Federal de Goiás (HC-UFG)	Goiânia
Brazil	Universidade Federal de Alagoas (UFAL)	Maceió
Brazil	Universidade Federal do Rio Grande do Norte	Natal	Rio Grande Do Norte
Brazil	Hospital de Clínicas de Porto Alegre - Universidade Federal do Rio Grande do Sul (HCPA-UFRGS)	Porto Alegre
Brazil	Instituto de Cardiologia/Fundação Universitária de Cardiologia do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional de Cardiologia (INC)	Rio De Janeiro
Brazil	Universidade Federal do Maranhão (UFMA)	São Luís
Brazil	Hospital do Coração (HCor)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-c	Low-density lipoprotein cholesterol (LDL-c), in mg/dL: LDL-c will be detected by Martins´mathematical formula	Changes in LDL-c after 16 weeks
Secondary	TC	Total cholesterol (TC), in mg/dL	Changes in TC after 16 weeks
Secondary	HDL-c	High-density lipoprotein cholesterol (HDL-c), in mg/dL	Changes in HDL-c after 16 weeks
Secondary	TG	Serum triglycerides (TG), in mg/dL	Changes in TG after 16 weeks
Secondary	VLDL-c	Very low-density lipoprotein cholesterol (VLDL-c), in mg/dL; serum triglycerides, (in mg/dL) divided by 5 will be used to report VLDL-c in mg/dL	Changes in VLDL after 16 weeks
Secondary	NHDL-c	Non-HDL cholesterol (NHDL-c), in md/dL; total cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report NHDL-c in mg/dL	Changes in NHDL-c after 16 weeks
Secondary	TG/HDL-c	TG/HDL-c ratio (TG/HDL-c), in mg/dL; serum triglycerides (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report TG/HDL-c in mg/dL	Changes in TG/HDL-c after 16 weeks
Secondary	Castelli I index	TC/HDL-c ratio, in mg/dL; total cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report Castelli I index in mg/dL	Changes in Castelli I index after 16 weeks
Secondary	Castelli II index	LDL-c/HDL-c ratio, in mg/dL; low-density lipoprotein cholesterol (in mg/dL) and high-density lipoprotein cholesterol (in mg/dL) will be combined to report Castelli II index in mg/dL	Changes in Castelli II index after 16 weeks
Secondary	FG	Fasting glucose (FG), in mg/dL	Changes in FG after 16 weeks
Secondary	INS	Serum insulin (INS), in mU/L	Changes in INS after 16 weeks
Secondary	HbA1C	glycated hemoglobin (HbA1C), in %	Changes in HbA1C after 16 weeks
Secondary	HOMA-IR	Homeostasis model assessment-insulin resistance, defined according to: [FG (in mmol) x INS (in UI/mL) ÷ 22.5]	Changes in HOMA-IR after 16 weeks
Secondary	BW	Body weight, in kg	Changes in BW after 16 weeks
Secondary	BMI	Body mass index (BMI), in kg/m^2; weight (in kg) and height (in meters) will be combined to report BMI in kg/m^2	Changes in BMI after 16 weeks
Secondary	WC	Waist circumference (WC), in cm	Changes in WC after 16 weeks
Secondary	HC	Hip circumference, in cm	Changes in HC after 16 weeks
Secondary	WHR	Waist-to-hip ratio (WHR); waist circumference (in cm) and hip circumference (in cm) will be combined to report WHR	Changes in WHR after 16 weeks
Secondary	WHt	Waist-to-height ratio (WHt); waist circumference (in cm) and height (in meters) will be combined to report WtH, in cm/m	Changes in WHt after 16 weeks