Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Nutrition-Based Approach to Reduce Heart Disease Risk Among Overweight African Americans: Use of Soul Food Plant-Based or Omnivorous Diets to Address Cardiovascular Disease
Brief Summary: This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:

Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:

1. Risk factors for CVD, including LDL cholesterol and blood pressure; and
2. Body weight.

   Secondary Aim
3. Examine long-term changes in CVD risk factors and body weight at 24 months.


Options:
A: Inclusion Criteria:

* Self-identify as African American
* Be between the ages of 18-65 years
* Body Mass Index between 25- 49.9 kg/m2
* Live in the Columbia, SC/Midlands area
* Be able to attend all monitoring and weekly class visits
* Be willing to be randomized to either diet

Exclusion Criteria:

* Currently following a vegan diet
* Diagnosed with diabetes that is controlled by medication
* Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* Under the age of 18 years old
* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Diagnosed with stroke or heart attack
B: A) Inclusion Criteria:

Eligible participants will be:

1. men, over 50
2. postmenopausal women, over 60 or
3. postmenopausal women under 60 with a family history of hypercholesterolemia and 1 CVD risk factor.

Participants will have the following characteristics:

* BMI 25-40 kg/m2 with body weight that has remained constant (within ±3%) over the last 3 months preceding the onset of the study
* Plus at least 1 of the following 3 criteria:

  1. have type 2 diabetes with one of the following:

     * raised LDL-C(in accordance with the 2012 Canadian Cardiovascular Society Guidelines)
     * raised BP (\> 130/80mmHg), or
     * active smoking;
  2. be non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy; and
  3. have a modified Framingham risk score \>20% (CCS 2012) and are unable (intolerant) or unwilling to take statin drugs.

B) Exclusion Criteria:

Individuals with the following conditions will be excluded:

* cardiovascular disease that precludes exercise e.g.

  * recent stroke or
  * myocardial infarction, or
* cardiac condition that compromises normal function

  * mitral valve disease,
  * heart failure--grades 2-4 (New York Heart Association classification),
  * severe angina or
  * other conditions preventing exercise,
* secondary causes of hypercholesterolemia

  * hypothyroidism, (unless treated and on a stable dose of L-thyroxine)
  * renal or liver disease
* uncontrolled blood pressure
* major disability
* disorder requiring continuous medical attention and treatment:

  * chronic heart failure,
  * liver disease,
  * renal failure or
  * cancer (except non-melanoma skin cancer--basal cell, squamous cell),
* chronic infections (bacterial or viral)
* chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
* other autoimmune diseases
* major surgery \<6 months prior to randomization
* alcohol consumption \>2 drinks/d.
C: Inclusion Criteria:

* Healthy, adult (age, 18-75 years) men and non-pregnant women;
* Overweight or obese (BMI \> 23 kg/m2 for Asian individuals and \> 25 kg/m2 other individuals);
* High waist circumference (\> 94 cm in men, \> 80 cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; \> 90 cm in men and \> 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals);
* Currently report drinking SSBs regularly (≥ 1 serving daily);
* Have a primary care physician;
* Nonsmoker;
* Free of any diseases or illnesses;
* Not regularly taking any medications that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators

Exclusion Criteria:

* Age \< 18 or \> 75 years;
* BMI \< 23 kg/m2 for Asian individuals and \< 25 kg/m2 other individuals;
* Waist circumference \< 94cm in men, \< 80cm in women in Europid, Sub-Saharan African, Eastern Mediterranean, and Middle Eastern individuals; \< 90cm in men and \< 80 cm in women for South Asian, Chinese, Japanese, and South and Central American individuals;
* Not regularly drinking SSBs (≥1 serving per day);
* Pregnant or breast feeding females, or women planning on becoming pregnant throughout study duration;
* Regular medication use that have a clinically relevant effect on the primary outcomes, as deemed inappropriate by investigators
* Antibiotic use in the last 3 months;
* Complementary or alternative medicine (CAM) use as deemed inappropriate by investigators;
* Self-reported diabetes;
* Self-reported uncontrolled hypertension (or systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥ 100 mmHg \[26\]);
* Self-reported polycystic ovarian syndrome;
* Self-reported cardiovascular disease;
* Self-reported gastrointestinal disease;
* Previous bariatric surgery;
* Self-reported liver disease;
* Self-reported uncontrolled hyperthyroidism or hypothyroidism;
* Self-reported kidney disease;
* Self-reported chronic infection;
* Self-reported lung disease;
* Self-reported cancer/malignancy;
* Self-reported schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, and dissociative disorders;
* Major surgery in the last 6 months;
* Other major illness or health-related incidence within the last 6 months;
* Smoker;
* Regular recreational drug users;
* Heavy alcohol use (\> 3 drinks/day);
* Do not have a primary care physician;
* Participation in any trials within the last 6 months or for the duration of this study;
* Individuals planning on making dietary or physical activity changes throughout study duration;
* If participating in MRI portion of study: any condition or circumstance which would prevent the participant from having an MRI (e.g. having prostheses or metal implants, tattoos, or claustrophobia)
D: Inclusion Criteria:

1. Are generally healthy men and women older than 18 years of age.
2. Are willing and able to undergo the informed consent process.
3. Have body mass index (BMI) from 25.0 to 34.9 kg/m².
4. Have one or more fasting plasma or serum glucose values of 90-150 mg/dl documented within 4 weeks of the initial study visit, or upon safety lab evaluation at the initial study visit.
5. Have blood pressure \> 120 mmHg systolic or \> 80 mmHg diastolic.
6. Are willing to notify the research staff of any change in their medical health \& concomitant medications/supplements during the course of the clinical trial.

Exclusion Criteria:

1. Intolerance, dislike, or unwillingness to consume raisins or any of the comparator snacks and affiliated ingredients.
2. History of \> one "food allergy."
3. Weight loss of \> 5 pounds in last 2 months
4. Prior diagnosis of diabetes mellitus or currently taking diabetes mellitus drugs (including drugs such as metformin and colesevelam HCl, even if not being taken for diabetes mellitus). Subjects with prior history of gestational diabetes mellitus are eligible, as long as they no longer have diabetes mellitus, and are no longer taking medications for diabetes mellitus.
5. Blood pressure \>160 mmHg systolic or \>100 mmHg diastolic.
6. Fasting serum lipoprotein values of: LDL-cholesterol, \>160 mg/dl or triglycerides, \>500 mg/dl.
7. Creatinine level \> 1.5 times the upper range of normal.
8. Potassium level above the upper range of normal (one repeat lab would be permitted if the initial elevated potassium level is thought possibly due to laboratory error)
9. Use of any medication or supplement to treat diabetes mellitus or blood glucose management at, or within 2 months prior to initial study entry.
10. Initiation or change of any antihypertensive medication within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two antihypertensive medications that is/are to be maintained at constant dose throughout the study.
11. Initiation or change of any lipid-altering drug within the two months prior to initial study entry. Subjects would be eligible if on stable dose of one or two lipid-altering drugs that is/are to be maintained at constant dose throughout the study.
12. Is pregnant, breastfeeding or plans to become pregnant during the next three months.
13. Is an employee or immediate family member of the research staff.
14. Donated blood within 2 months prior to study entry, or plans to donate blood during the course of this study.
15. Use of systemic corticosteroids (intravenous, subcutaneous, intra-articular). Inhaled and intranasal corticosteroids are permitted.
16. Use of antiobesity/weight maintenance drug therapies at initial study visit, or within 2 months of the initial study visit.
17. Known medical history of clinical significance, or any other conditions that would present unacceptable risk to study subject, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study as per discretion of the Principal Investigator.
18. History of severe or uncontrolled depression based on Principal Investigator.
19. Known laboratory abnormalities prior to randomization which Principal Investigator deems may pose an unacceptable risk, compromise acquisition or interpretation of study data, or otherwise interfere with the study subject's participation in the study.
20. Major surgical procedure within 30 days prior to visit #1 (i.e. day of signing of the informed consent document), or current plans to have a major surgical procedure during study participation or 30 days following completion of all study related procedures.
21. History of gastrointestinal malabsorption (e.g. uncontrolled crohn's disease, etc.) or history of a gastric bypass or other diversional bariatric surgery. Gastric banding procedure is also exclusionary if adjusted within 30 days prior to visit #1 (i.e. day of signing the informed consent document), or a reasonable chance of having a gastric banding adjustment during the course of the study.
22. History of ongoing malignancy. Malignancy that has been successfully treated, with no evidence of persistence or recurrence of the malignancy within 5 years of visit #1 (i.e. day of signing the informed consent document) or basal carcinoma of the skin and "in situ" cancer of the cervix successfully treated 30 days prior to visit #1 are acceptable.
23. History of organ transplant.
24. History of drug (licit or illicit) or alcohol abuse/addiction within 5 years of visit #1 (i.e. day of signing the informed consent document).
25. Consumes more than 2 units of alcohol per day. A unit of alcohol is defined as a 12 ounce (350 ml) beer, 5 ounce (150 ml) wine, or 1.5 ounce (45 ml) of 80-proof alcohol for mixed drinks.
26. Known positive testing for hepatitis B surface antigen, hepatitis C antibody, active hepatitis A immunoglobulin M, or human immunodeficiency virus.
27. Anticipation of a significant change in job, job duties, or job work hours, which might impair their ability and willingness to undergo study-related procedures under the timelines specified by protocol, and otherwise impede their completion of the study.
28. Anticipation of or a reasonable likelihood of moving away from the research site, wherein such a move might impair their ability and willingness to undergo study-related procedures within the timelines specified by protocol, or otherwise impede their completion of the study.
29. Anticipation of or a reasonable likelihood of vacations or other times away from home which might impair their ability and willingness to undergo study-related procedures within the timelines specified by the study protocol, or otherwise impede their completion of the study.
30. Planned or anticipated major changes in lifestyle health practices, unless allowed by study protocol. Therapeutic Lifestyle Changes counseling will take place at randomization.
31. Treatment with an investigational product or an investigational device within 30 days prior to visit #1 (i.e. day of signing the informed consent document) and have no plans to potentially start any investigational product or use an investigational device during or 30 days after the study subject completes all study related procedures.
32. Reasonable life-expectancy of less than 2 years.
33. Any other reason, if in the opinion of the Investigator, the individual study subject is not appropriate, or suitable for participation in the clinical trial.

Answer: A