Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CI-023 | Other Identifier | Comité de Investigación del Hospital Central del Estado |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WFPBD Group | Experimental | The participants in this group follow a Whole Food Plant-Based Diet for 8 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Risk | Estimate of the 10-year risk of myocardial infarction or death calculated by the Framingham score for coronary artery disease | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Maximum pressure exerted by the heart when it beats measured in mmHg | 8 weeks |
| Percentage of body fat | Estimated percentage of fat mass using bioimpedance |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body weight measured by kilograms | 8 weeks |
| Waist circumference | Waist circumference measured in centimeters | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luis B EnrÃquez Sánchez, M.D. | Universidad Autonoma de Chihuahua | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Central del Estado de Chihuahua | Chihuahua City | 31000 | Mexico |
The data obtained from this research study will be available if requested once the study is finalized.
The data will be available for up to five years since completion of the study.
The request for the data will be by e-mail.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 13, 2024 | |
| Reset | Aug 15, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 13, 2024 | Aug 15, 2024 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| D000095500 | Diet, Plant-Based |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Prospective study, randomized pilot clinical trial.
Not provided
Not provided
Due to the nature of the intervention (type of diet) is not possible to mask either the participants or the investigator.
|
|
| Nutritional Standard Care | Behavioral | Nutritional Consultation every month for 2 months. Recommendations on healthy eating and lifestyle will be given. Duration 8 weeks |
|
|
| 8 weeks |
| LDL cholesterol | Type of lipoprotein measured in milligrams per deciliter | 8 weeks |
| Percentage of body muscle mass | Estimated percentage of muscle mass using bioimpedance | 8 weeks |
| D007239 |
| Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |