Whole Food Plant-Based Diet for HIV-Associated Reduction in Cardiovascular Risk (PLANT-HART)
Condition: Heart Diseases; Hiv
MeSH terms: Heart Diseases
Study type: Interventional

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.
    

Intervention name(s): Whole Food Plant-Based Diet Ad Libitum; Nutritional Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; Nutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks
Other intervention name(s): Vegan diet; Plant-based diet; Nutritional Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study, randomized pilot clinical trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Heart disease; Risk Factors; Plant-based; Cardiovascular