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

NCT ID: NCT05796882

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2023-07-14

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.

Conditions

Heart Diseases; Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

WFPBD Group

The participants in this group follow a Whole Food Plant-Based Diet for 8 weeks

Group Type: EXPERIMENTAL

Whole Food Plant-Based Diet Ad Libitum

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Nutritional Standard Care

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Nutritional Standard Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Vegan diet; Plant-based diet; Nutritional Counseling

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Autonoma de Chihuahua

OTHER

Sponsor Role: lead

Responsible Party

Carolina Martínez Loya, MD

Médico Pasante de Servicio Social

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis B Enríquez Sánchez, M.D.

Role: STUDY_DIRECTOR

Universidad Autonoma de Chihuahua

Locations

Hospital Central del Estado de Chihuahua

Chihuahua City, , Mexico

Countries

Mexico

Other Identifiers

CI-023

Identifier Type: OTHER

Identifier Source: secondary_id

023C-03/23

Identifier Type: -

Identifier Source: org_study_id