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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Hiv
• Intervention / Treatment: Behavioral: Whole Food Plant-Based Diet Ad Libitum; Behavioral: Nutritional Standard Care

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Chihuahua, Mexico, 31000
    • Hospital Central del Estado de Chihuahua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WFPBD Group; The participants in this group follow a Whole Food Plant-Based Diet for 8 weeks	Behavioral: Whole Food Plant-Based Diet Ad Libitum; 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
Active Comparator: Nutritional Standard Care Group; 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; Nutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks; Other Names: Nutritional Counseling

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Body weight measured by kilograms	8 weeks
Waist circumference	Waist circumference measured in centimeters	8 weeks

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Chihuahua
• Investigators: Study Director: Luis B Enríquez Sánchez, M.D., Universidad Autonoma de Chihuahua

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Cardiovascular; Risk Factors; Heart disease; Plant-based
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 023C-03/23; CI-023 (Other Identifier: Comité de Investigación del Hospital Central del Estado)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data obtained from this research study will be available if requested once the study is finalized.
• IPD Sharing Time Frame: The data will be available for up to five years since completion of the study.
• IPD Sharing Access Criteria: The request for the data will be by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No