Whole Food Plant-Based Diet for HIV-Associated Reduction in Cardiovascular Risk (PLANT-HART)

Not Applicable

Completed

• Conditions: Heart Diseases; Hiv
• Interventions: Behavioral: Whole Food Plant-Based Diet Ad Libitum; Behavioral: Nutritional Standard Care

• Registration Number: NCT05796882
• Lead Sponsor: Universidad Autonoma de Chihuahua

Brief Summary

The goal of this clinical trial is to evaluate the impact of using a whole food plant-based diet in the reduction of cardiovascular risk related to HIV in people who live with HIV infection.

The main questions it aims to answer are:

* Does a whole food plant-based diet, nonrestrictive in calories and low in fat, reduce the cardiovascular risk associated with HIV infection in people with HIV infection?

* Does the whole food plant-based diet permit achievement goals in specific metabolic markers of cardiovascular risk (such as Cholesterol, C Reactive Protein)? Participants will follow a non-calorie restricted, low fat, whole food plant-based diet for 8 weeks Researchers will compare standard nutritional care to see if there is a difference in the main outcomes

Detailed Description

The participants in the group within the intervention will follow a Whole Food Plant-Based Diet for 8 weeks, which consists of increasing the daily consumption of fruits and vegetables, including sources of vegetable protein such as legumes (beans, lentils, chickpeas, peas, etc. ), soybeans and their derivatives (tofu, textured soybeans, soymilk), and whole grains (oats, wheat, rice, quinoa, corn), nuts and seeds high in omega-3 fatty acids (chia, flaxseed, hemp ), minimize processed foods and foods high in saturated fat. There will be no caloric restriction, however, visual support will be provided, in the form of a traffic light, to distinguish the frequency with which each type of food can be consumed. A small recipe book will be provided with suggestions for breakfast, lunch, and dinner dishes. Patients will receive vitamin b12 supplements of 1000 micrograms twice a week.

There will be no caloric restriction, however, visual support will be provided, in the form of a traffic light, to distinguish the frequency with which each type of food can be consumed. A small recipe book will be provided with suggestions for breakfast, lunch, and dinner dishes. Patients will receive vitamin b12 supplements of 1000 micrograms twice a week.

The participants in the other group will attend a consultation with a nutritionist every month in which will receive recommendations about nutrition and lifestyle in order to reduce cardiovascular risk.

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-04
• Study Start: 2023-05-19
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Over 20 years but under 60 years
• Individuals with a BMI >25
• Individuals with some classic cardiovascular risk factor (dyslipidemia, smoking, type 2 diabetes mellitus, systemic arterial hypertension, obesity)
• Individuals under ART with adequate CD4+ cell count and viral load undetectable

Exclusion Criteria

• Patients currently diagnosed with AIDS
• Patients who have suffered an AMI and/or stroke
• Patients who use drugs
• Patients who have had poor adherence to ART

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WFPBD Group	Whole Food Plant-Based Diet Ad Libitum	The participants in this group follow a Whole Food Plant-Based Diet for 8 weeks
Nutritional Standard Care Group	Nutritional Standard Care	The participants in this group receive a nutritional consultation every month with dietetic guidance and recommendations about a healthy lifestyle, duration 8 weeks

Primary Outcome Measures

Name	Time	Method
Cardiovascular Risk	8 weeks	Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease

Secondary Outcome Measures

Name	Time	Method
Percentage of body muscle mass	8 weeks	Estimated percentage of muscle mass using bioimpedance
LDL cholesterol	8 weeks	Type of lipoprotein measured in milligrams per deciliter
Systolic Blood Pressure	8 weeks	Maximum pressure exerted by the heart when it beats measured in mmHg
Percentage of body fat	8 weeks	Estimated percentage of fat mass using bioimpedance

Trial Locations

Locations (1)

Hospital Central del Estado de Chihuahua; 🇲🇽 Chihuahua, Mexico