A Whole Food Plant Diet and Its Lipidemic Effects on Primary Prevention in a Free-range Population
A Whole Food Plant Diet and Its Lipidemic Effects on Primary Prevention in a Free-range Population
This study seeks to determine the effects of a whole-food, plant-based diet on lipid,
 metabolic, and inflammatory biomarkers. Eligible participants will have had either an LDL-C
 >100 mg/dL or non-HDL-C >130 mg/dL without a current diagnosis of coronary heart disease and
 are willing to adhere to a whole food plant based diet for at least 8 weeks. Participants
 enrolled in the study will provide fasting blood work, complete a baseline quality of life
 survey, and receive education on a whole-food, plant-based diet at a local Lancaster County
 grocery store during their first study visit. Throughout the study, patients will have access
 to dietary counseling which will be provided by a certified nutritionist and will be asked to
 record and submit daily food diaries. Study participants will be asked to adhere to a whole
 food plant based diet for a total of 8 weeks. Prior to the final study visit, participants
 will be asked to obtain follow-up fasting bloodwork around 7 weeks post start of whole food
 plant based diet. The results, along with a follow-up quality of life survey, and an
 opportunity to discuss the bloodwork with a doctor will be held at the local grocery story 8
 weeks after the first study visit.
CHD remains the leading cause of death in numerous developed countries and is estimated to
 cause one-third of all deaths in patients over the age of 35. 28 While CVD is preventable,
 studies suggest that a range of lifestyle factors including physical inactivity, nicotine
 abuse, and nutrition practices are increasing the prevalence of the disease in most
 countries. 28,29 Such facts highlight the importance of lifestyle interventions. Despite the
 chronic nature of cardiovascular disease, even short-term studies analyzing ad libitum
 plant-based diets reveal significantly improved changes in commonly tested biomarkers that
 predict cardiovascular disease risk. 30 While a number of studies have explored the
 lipid-lowering effects of traditional vegetarian diets, 31 few studies have explored the
 effects of a whole-food, plant-based diet despite its proposed benefits. Preliminary studies
 suggest that such a diet might facilitate weight loss and lead to improvements in lipid
 parameters.32 To this end, we propose a study to implement a whole-food, plant based diet
 intervention in the Lancaster community to quantify its ability to modify lipid, metabolic
 and inflammatory biomarkers.

 This single-arm diet pilot study seeks to determine the serologic effects of a whole-food,
 plant-based diet on primary prevention subjects in a free-range environment. Eligible
 participants will have had either an LDL-C >100 mg/dL or non-HDL-C >130 mg/dLwithout a
 current diagnosis of coronary heart disease and are willing to adhere to a whole food plant
 based diet for at least 8 weeks.

 A total of 50 subjects will be enrolled to the study. Participants enrolled in the study will
 provide fasting blood work and receive education on a whole-food, plant-based diet at a local
 Lancaster County grocery store during their first study visit. At this time, the study
 coordinator will also document the patient's height, weight, and hip and waist circumference.
 While subjects are waiting to provide a blood draw, study personnel will administer two
 baseline questionnaires to each subject. The first questionnaire will be the SF12
 quality-of-life survey. The second survey will capture pertinent elements of the patient's
 medical history and ask the patient questions on motivation, attitude, and expected
 compliance to the diet.They will be served a catered vegan breakfast and receive a lecture on
 a whole-food, plant-based diet by Dr. Christopher Wenger. Dr. Wenger also will train the
 subjects on the use of the study food record. At the end of the session, a certified
 nutritionist will give a tour of the local grocery store to show subjects how to select
 appropriate low-cost foods for the dietary intervention. Following the conclusion of the
 study visit, subjects will begin the interventional phase of the study and follow a
 whole-food, plant-based diet for eight weeks. The dietary intervention will conclude with the
 post-intervention study visit. Throughout the study, patients will have access to dietary
 counseling which will be provided by a certified nutritionist

 The post-intervention study visit (8 weeks after the initial visit) will be held at the
 conference room in the local grocery story and will comprise the same cohort which began the
 study together at the baseline study visit. Prior to distributing each subject's results,
 study personnel will administer the SF12 quality-of-life survey and measure each subject's
 weight and hip and waist circumference post-intervention. Study personnel will also
 administer a questionnaire assessing each subject's experience on the diet including
 challenges, motivation, and attitudes toward the diet. We will also capture how likely the
 patient is to continue on the diet after the conclusion of the study.

 Study personnel will then disseminate each patient's lab results pre- and post-intervention.
 At this time, subjects will be given the opportunity to discuss their results with Dr.
 Wenger. A catered vegan lunch will be served during the study visit.
Inclusion Criteria:

 -  Age ≥ 18 years old

 -  Indicated willingness to adhere to whole-food plant-based diet

 -  Patient recommended for dietary intervention by healthcare provider

 -  LDL-C >100 mg/dL or non-HDL-C >130 mg/dL documented by a lab test in the LG EMR within
 the last 6 months

 Exclusion Criteria:

 -  Any condition that, in the opinion of the patient's healthcare provider, will
 adversely affect study execution or data collection