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

Hiv Clinical Trial

— PLANT-HART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796882
• Other study ID #: 023C-03/23
• Secondary ID: CI-023
• Status: Completed
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: July 14, 2023

Study information

• Verified date: August 2023
• Source: Universidad Autonoma de Chihuahua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Hiv

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Central del Estado de Chihuahua	Chihuahua

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Chihuahua

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Body weight measured by kilograms	8 weeks
Other	Waist circumference	Waist circumference measured in centimeters	8 weeks
Primary	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	Systolic Blood Pressure	Maximum pressure exerted by the heart when it beats measured in mmHg	8 weeks
Secondary	Percentage of body fat	Estimated percentage of fat mass using bioimpedance	8 weeks
Secondary	LDL cholesterol	Type of lipoprotein measured in milligrams per deciliter	8 weeks
Secondary	Percentage of body muscle mass	Estimated percentage of muscle mass using bioimpedance	8 weeks