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

Sponsor
Universidad Autonoma de Chihuahua (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05796882
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
2
Anticipated Duration (Months)
29.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Whole Food Plant-Based Diet Ad Libitum
  • Behavioral: Nutritional Standard Care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective study, randomized pilot clinical trial.Prospective study, randomized pilot clinical trial.
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.
Primary Purpose:
Prevention
Official Title:
Impact of the Whole Food Plant-Based Diet in HIV-Associated Reduction in Cardiovascular Risk
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular Risk [8 weeks]

      Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease

    Secondary Outcome Measures

    1. Systolic Blood Pressure [8 weeks]

      Maximum pressure exerted by the heart when it beats measured in mmHg

    2. Percentage of body fat [8 weeks]

      Estimated percentage of fat mass using bioimpedance

    3. LDL cholesterol [8 weeks]

      Type of lipoprotein measured in milligrams per deciliter

    4. Percentage of body muscle mass [8 weeks]

      Estimated percentage of muscle mass using bioimpedance

    Other Outcome Measures

    1. Weight [8 weeks]

      Body weight measured by kilograms

    2. Waist circumference [8 weeks]

      Waist circumference measured in centimeters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Over 30 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Central del Estado de Chihuahua Chihuahua Mexico 31000

    Sponsors and Collaborators

    • Universidad Autonoma de Chihuahua

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carolina Martínez Loya, MD, Médico Pasante de Servicio Social, Universidad Autonoma de Chihuahua
    ClinicalTrials.gov Identifier:
    NCT05796882
    Other Study ID Numbers:
    • 023C-03/23
    • CI-023
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Carolina Martínez Loya, MD, Médico Pasante de Servicio Social, Universidad Autonoma de Chihuahua
    HIV
    Heart disease
    Risk Factors
    Plant-based
    Cardiovascular
    Additional relevant MeSH terms:
    Heart Diseases

    Study Results

    No Results Posted as of Apr 4, 2023