Loading search results

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 LibitumBehavioral

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

MeSH Terms

Conditions

Heart DiseasesAcquired Immunodeficiency Syndrome

Interventions

Diet, VeganDiet, Plant-BasedNutrition Assessment

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae Infections

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

Model Details: Prospective study, randomized pilot clinical trial.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Médico Pasante de Servicio Social

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Study Arms (2)

WFPBD Group

Nutritional Standard Care Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Study Arms (2)

WFPBD Group

Nutritional Standard Care Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations