Clinical trial NCT05796882: Whole Food Plant-Based Diet for HIV-Associated Reduction in Cardiovascular Risk (PLANT-HART)
Official title: Impact of the Whole Food Plant-Based Diet in HIV-Associated Reduction in Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Hiv
Keywords: HIV
Heart disease
Risk Factors
Plant-based
Cardiovascular
Lead sponsor: Universidad Autonoma de Chihuahua
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective study, randomized pilot clinical trial.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Cardiovascular Risk
timeFrame: 8 weeks
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: 8 weeks
measure: Percentage of body fat
timeFrame: 8 weeks
measure: LDL cholesterol
timeFrame: 8 weeks
measure: Percentage of body muscle mass
timeFrame: 8 weeks
Other outcomes:
measure: Weight
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
Locations:
city: Chihuahua
country: Mexico
facility: Hospital Central del Estado de Chihuahua
Study officials:
affiliation: Universidad Autonoma de Chihuahua
name: Luis B Enríquez Sánchez, M.D.
role: STUDY_DIRECTOR
References: