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

NCT05796882 | Completed

• 2 other identifiers: 023C-03/23CI-023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Diseases; Hiv

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Systolic Blood Pressure

  8 weeks

• Percentage of body fat

  8 weeks

• LDL cholesterol

  8 weeks

• Percentage of body muscle mass

  8 weeks

Other Outcomes (2)

• Weight

  8 weeks

• Waist circumference

  8 weeks

Study Arms (2)

WFPBD Group

EXPERIMENTAL

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

Behavioral: Whole Food Plant-Based Diet Ad Libitum

Nutritional Standard Care Group

ACTIVE COMPARATOR

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

Interventions

Whole Food Plant-Based Diet Ad Libitum 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

Also known as: Vegan diet, Plant-based diet

WFPBD Group

Nutritional Standard Care BEHAVIORAL

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

Also known as: Nutritional Counseling

Nutritional Standard Care Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Chihuahua: lead

Study Sites (1)

Hospital Central del Estado de Chihuahua

Chihuahua City, 31000, Mexico

Location

MeSH Terms

Conditions

Heart Diseases; Acquired Immunodeficiency Syndrome

Interventions

Diet, Vegan; Diet, Plant-Based; Nutrition Assessment

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Luis B Enríquez Sánchez, M.D.

  Universidad Autonoma de Chihuahua

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention (type of diet) is not possible to mask either the participants or the investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médico Pasante de Servicio Social

Model Details: Prospective study, randomized pilot clinical trial.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: May 19, 2023
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available for up to five years since completion of the study.
• Access Criteria: The request for the data will be by e-mail.

Locations

ME (1)