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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of the Whole Food Plant-Based Diet in HIV-Associated Reduction in Cardiovascular Risk

Conditions
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Heart Diseases, Hiv

Intervention / Treatment
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* Behavioral: Whole Food Plant-Based Diet Ad Libitum
* Behavioral: Nutritional Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective study, randomized pilot clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WFPBD Group<br>The participants in this group follow a Whole Food Plant-Based Diet for 8 weeks | Behavioral: Whole Food Plant-Based Diet Ad Libitum<br>* Participants will follow a Low Fat Whole Food Plant-Based Diet Ad Libitum for 8 weeks. It 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), and minimize processed foods, and foods high in saturated fat. Avoiding animal-sourced foods. 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<br>* Other names: Plant-based diet;|
| Active Comparator: Nutritional Standard Care Group<br>The participants in this group receive a nutritional consultation every month with dietetic guidance and recommendations about a healthy lifestyle, duration 8 weeks | Behavioral: Nutritional Standard Care<br>* Nutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks<br>* Other names: Nutritional Counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Risk | Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Heart disease, Risk Factors, Plant-based, Cardiovascular