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NCT Number: NCT05796882

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

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

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Key information

Conditions

Heart Diseases Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Central del Estado de Chihuahua

Chihuahua City, 31000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Food Plant-Based Diet Ad Libitum

Behavioral

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

Other names: Vegan diet, Plant-based diet

Nutritional Standard Care

Behavioral

Nutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks

Other names: Nutritional Counseling

Primary outcomes

  1. Cardiovascular Risk

    Time frame: 8 weeks

    Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: 8 weeks

    Maximum pressure exerted by the heart when it beats measured in mmHg

  2. Percentage of body fat

    Time frame: 8 weeks

    Estimated percentage of fat mass using bioimpedance

  3. LDL cholesterol

    Time frame: 8 weeks

    Type of lipoprotein measured in milligrams per deciliter

  4. Percentage of body muscle mass

    Time frame: 8 weeks

    Estimated percentage of muscle mass using bioimpedance

Other outcomes

  1. Weight

    Time frame: 8 weeks

    Body weight measured by kilograms

  2. Waist circumference

    Time frame: 8 weeks

    Waist circumference measured in centimeters

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Chihuahua

Other

Registry information

Official study title

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

Acronym: PLANT-HART

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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