Heart DiseasesPLANT-HARTNCT05796882
Whole Food Plant-Based Diet for HIV-Associated Reduction in Cardiovascular Risk (PLANT-HART)
A study testing Whole Food Plant-Based Diet Ad Libitum in people with Heart Diseases and Hiv, run by Universidad Autonoma de Chihuahua at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Heart Diseases, Hiv
- What is being tested?
- Whole Food Plant-Based Diet Ad Libitum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 19 May 2023to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Whole Food Plant-Based Diet in HIV-Associated Reduction in Cardiovascular Risk
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
Read the 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.
- Conditions
- Heart Diseases, Hiv
- Being tested
- Whole Food Plant-Based Diet Ad Libitum, Nutritional Standard Care
- Keywords
- HIV, Heart disease, Risk Factors, Plant-based, Cardiovascular
- Medical subject headings
- Heart Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food Plant-Based Diet Ad LibitumBehavioural
Also called Vegan diet, Plant-based diet
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
Nutritional Standard CareBehavioural
Also called Nutritional Counseling
Nutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| WFPBD Group | Experimental | The participants in this group follow a Whole Food Plant-Based Diet for 8 weeks Receives: 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 Receives: Behavioral: Nutritional Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Risk
Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease
Measured: 8 weeks
Secondary outcomes (4)
Systolic Blood Pressure
Maximum pressure exerted by the heart when it beats measured in mmHg
Measured: 8 weeks
Percentage of body fat
Estimated percentage of fat mass using bioimpedance
Measured: 8 weeks
LDL cholesterol
Type of lipoprotein measured in milligrams per deciliter
Measured: 8 weeks
Percentage of body muscle mass
Estimated percentage of muscle mass using bioimpedance
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start19 May 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study, randomized pilot clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Chihuahua
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Martínez Loya, MD, Universidad Autonoma de Chihuahua
- Investigators
- Luis B Enríquez Sánchez, M.D., Study director, Universidad Autonoma de Chihuahua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796882
- Sponsor's protocol ID
- 023C-03/23
- Other IDs
- CI-023
- Acronym
- PLANT-HART
- Status last verified
- Aug 2023
- First submitted
- 21 Mar 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data obtained from this research study will be available if requested once the study is finalized.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Whole Food Plant-Based Diet in HIV-Associated Reduction in Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05796882
- Acronym / sponsor ID
- PLANT-HART / 023C-03/23
- Conditions
- Heart Diseases, Hiv
- Keywords
- HIV, Heart disease, Risk Factors, Plant-based, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad Autonoma de ChihuahuaUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study, randomized pilot clinical trial.
| Arm | Type | Receives |
|---|---|---|
| WFPBD Group | Experimental | Behavioral: Whole Food Plant-Based Diet Ad LibitumThe participants in this group follow a Whole Food Plant-Based Diet for 8 weeks |
| Nutritional Standard Care Group | Active comparator | Behavioral: Nutritional Standard CareThe participants in this group receive a nutritional consultation every month with dietetic guidance and recommendations about a healthy lifestyle, duration 8 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Food Plant-Based Diet Ad LibitumAlso: Vegan diet, Plant-based dietParticipants 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 | Behavioural | WFPBD Group |
| Nutritional Standard CareAlso: Nutritional CounselingNutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks | Behavioural | Nutritional Standard Care Group |
Primary outcome
Cardiovascular Risk
Time frame: 8 weeks
Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease
4 secondary outcomes
Systolic Blood Pressure
Time frame: 8 weeks
Percentage of body fat
Time frame: 8 weeks
LDL cholesterol
Time frame: 8 weeks
Percentage of body muscle mass
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Yes. The data obtained from this research study will be available if requested once the study is finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis B Enríquez Sánchez, M.D. study director
Universidad Autonoma de Chihuahua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Plant-Based Diet Ad Libitum in people with Heart Diseases and Hiv, run by Universidad Autonoma de Chihuahua at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Risk (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.