Help Everyone Assess Risk Today: LEnten Nutrition Study (HEART-LENS)

NCT05057650 | Completed

• 1 other identifier: 19020103
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.Measuring baseline risk factors
2. 2.Educating them about their individual risk for heart disease
3. 3.Providing education on healthy lifestyle
4. 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. 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. 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).

Conditions

Cardiovascular Morbidity; Risk Reduction; Nutrition Disorders

Keywords

Nutrition Intervention; plant-based nutrition; cardiovascular risk modification

Outcome Measures

Primary Outcomes (1)

• American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator, ranging from 1% to 50% 10-year event risk

  ACC/AHA Guideline for Prevention Tool calculated based on blood pressure, total cholesterol, HDL cholesterol, diabetes, age, gender, ethnicity, and smoking history.

  5 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Vegan food for 5 weeks: approximately 50 participants volunteered for the intervention.

Dietary Supplement: Vegan diet

Interventions

Vegan diet DIETARY_SUPPLEMENT

Provide

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Able to consent to dietary protocol
• Willing to comply with study requirements and voluntarily agrees to participate in this clinical study after appropriate informed consent is provided.

You may not qualify if:

• Vegetarians
• Inability to regularly measure blood pressure if taking antihypertensive medications
• Inability to regularly measure blood sugar if taking antihyperglycemic medications
• Celiac disease (gluten enteropathy)
• Treatment for eating disorder
• Active treatment for malignancy
• Inability to eat solid food
• Fruit, nut or vegetable
• Age \>18
• Able to consent to dietary protocol
• Willing to comply with study requirements and voluntarily agrees to participate in this clinical study after appropriate informed consent is provided.
• Vegetarians
• Inability to regularly measure blood pressure if taking antihypertensive medications
• Inability to regularly measure blood sugar if taking antihyperglycemic medications
• Celiac disease (gluten enteropathy)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior; Nutrition Disorders

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Behavior; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiology Division, James B. Herrick Professor of Medicine

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 27, 2021
• Study Start: March 3, 2019
• Primary Completion: April 20, 2019
• Study Completion: March 20, 2020
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)