Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05057650 |
| Other study ID # |
19020103 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 3, 2019 |
| Est. completion date |
March 20, 2020 |
Study information
| Verified date |
September 2021 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
Design and Methods:
A prospective study design will be implemented. Approximately 50 participants are expected to
volunteer for the intervention. The health screening will consist of measuring stations.
After signing an informed consent and a waiver, the participant will complete an intake form,
which includes basic patient information and demographics including date of birth, gender,
height, and race/ethnicity. Also on the intake form, the participant will list medications
currently being taken, risk factors for heart disease (i.e., diabetes, hypertension,
hyperlipidemia, and smoking), family history of heart disease, and current medical
conditions. After completing the intake form, the participant will have their height, weight,
blood pressure, and pulse measured. If the participant uses oxygen regularly or is feeling
short of breath, oxygen saturation will be measured using a pulse oximeter. Finally, each
participant will have a blood tests for fasting (preferably for 9 hours) blood glucose,
hemoglobin A1C, insulin level, lipid profile, high-sensitivity C-reactive protein, small
dense LDL cholesterol, lipoprotein a, trimethylamine N-oxide (TMAO) and suPAR at baseline.
Each of these parameters will be repeated for comparison at day 40 of Lent (Easter weekend).
Blood will be stored for future analysis, since assays for suPAR and TMAO may not be
immediately available.
From the information gathered, each participant will be given a baseline American College of
Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease
(ASCVD) risk score, which is an estimate of the 10-year and lifetime risks of ASCVD (defined
as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke). After the
last visit, health education and counseling will be provided which is tailored to each
individual given the findings gathered during the initial screening and the change that
occurred. The information gathered will be written down on a form for the participant to keep
for his own records. Referrals to primary care physicians, cardiologists, or other healthcare
providers will be given as needed after the initial or post-intervention risk assessment.
Patients who undergo lipid, blood pressure or glucose lowering therapy between the two
assessments will be censured from the appropriate laboratory data analysis.
Subject Selection:
Approximately 50 subjects will be enrolled.
Inclusion Criteria:
1. Age >18
2. Able to consent to dietary protocol
3. Willing to comply with study requirements and voluntarily agrees to participate in this
clinical study after appropriate informed consent is provided.
Exclusion Criteria:
1. Vegetarians
2. Inability to regularly measure blood pressure if taking antihypertensive medications
3. Inability to regularly measure blood sugar if taking antihyperglycemic medications
4. Celiac disease (gluten enteropathy)
5. Treatment for eating disorder
6. Active treatment for malignancy
7. Inability to eat solid food
8. Fruit, nut or vegetable allergy
Study Variables:
1. Demographic information (date of birth, race/ethnicity)
2. Height
3. Weight
4. Body mass index (BMI)
5. Patient names, addresses and phone numbers
6. History of known coronary artery disease (CAD)
7. CAD risk factors (age, gender, hypertension, diabetes mellitus (DM), dyslipidemia,
current or prior tobacco use, and family history of premature CAD),
8. History of typical angina pectoris,
9. CAD risk equivalents (peripheral or carotid arterial disease, stroke, transient ischemic
attack, chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.7m2
or end-stage renal disease).
10. Medications including aspirin, lipid lowering agent, antihypertensive and
antihyperglycemic.
11. Home blood pressure and blood glucose measurements at least 3 days per week.
Laboratory Tests Samples will be collected from individuals being evaluated at the baseline
and blood upon re-evaluation at day 40 of Lent:
1. Blood glucose
2. Glycosylated hemoglobin
3. Insulin level
4. Lipid profile
5. High-sensitivity C-reactive protein
6. Small dense low-density lipoprotein (LDL) cholesterol
7. Lipoprotein a
8. trimethylamine oxide (TMAO)
9. soluble urokinase plasminogen activator receptor (suPAR)
