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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05796882
Acronym
PLANT-HART
Enrollment
10
Registered
2023-04-04
Start date
2023-05-19
Completion date
2023-07-14
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases, Hiv

Keywords

HIV, Heart disease, Risk Factors, Plant-based, Cardiovascular

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.

Interventions

BEHAVIORALWhole 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

BEHAVIORALNutritional Standard Care

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

Sponsors

Universidad Autonoma de Chihuahua
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the intervention (type of diet) is not possible to mask either the participants or the investigator.

Intervention model description

Prospective study, randomized pilot clinical trial.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular Risk8 weeksEstimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease

Secondary

MeasureTime frameDescription
Systolic Blood Pressure8 weeksMaximum pressure exerted by the heart when it beats measured in mmHg
Percentage of body fat8 weeksEstimated percentage of fat mass using bioimpedance
LDL cholesterol8 weeksType of lipoprotein measured in milligrams per deciliter
Percentage of body muscle mass8 weeksEstimated percentage of muscle mass using bioimpedance

Other

MeasureTime frameDescription
Weight8 weeksBody weight measured by kilograms
Waist circumference8 weeksWaist circumference measured in centimeters

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026