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NCT05057650 · ClinicalTrials.gov registry record · NA
Help Everyone Assess Risk Today: LEnten Nutrition Study (HEART-LENS)
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT05057650: Completed NA study, sponsored by Rush University Medical Center.
NCT05057650 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05057650, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically improves their lifestyle by "giving up for Lent" certain foods or habits. Participation in this nutrition intervention is voluntary and each participant will sign an informed consent along with a waiver. On the waiver, the participant can agree to have all testing performed but can withdraw consent at any time or decide to have only some of the testing. It was hypothesized that a community-based health screening and nutritional intervention will have a positive impact on the participants by: 1. Measuring baseline risk factors 2. Educating them about their individual risk for heart disease 3. Providing education on healthy lifestyle 4. Providing a nutritional intervention for 40 days with home- delivered plant-based meals nutrition that has been shown to lower cardiac risk factors 5. Repeating the risk factor assessment at the end of the intervention, to demonstrate the degree of, if any, reduction in cardiac risk as assessed by the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator 6. Motivating at-risk subjects to seek continued appropriate medical care and to institute more permanent relevant lifestyle changes (e.g., diet, exercise, medication compliance).
Primary Outcome
ACC/AHA Guideline for Prevention Tool calculated based on blood pressure, total cholesterol, HDL cholesterol, diabetes, age, gender, ethnicity, and smoking history.
Interventions
- DIETARY_SUPPLEMENT Vegan diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-03-03 |
| Est. Completion | 2020-03-20 |
| Phase | NA |
What the finished NCT05057650 record still lists
NCT05057650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Vegan diet is the first listed.
NCT05057650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05057650 about?
NCT05057650 is a clinical study titled "Help Everyone Assess Risk Today: LEnten Nutrition Study (HEART-LENS)". The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically impr...
What is the current status of trial NCT05057650?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2019-03-03. Estimated completion is 2020-03-20.
What interventions are being tested in trial NCT05057650?
The interventions under investigation include: Vegan diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05057650?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05057650's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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