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A Whole Food Plant Diet and Its Lipidemic Effects on Primary Prevention in a Free-range Population (WholeLIFE)

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ClinicalTrials.gov Identifier: NCT03523247
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Louise von Hess Medical Research Institute
Information provided by (Responsible Party):
Lancaster General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diet Modification Cardiology Behavioral: whole food, plant based diet Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Whole Food, Plant Based Diet and Its Lipidemic Effects on Primary Prevention Population in a Free-range Environment - a Pilot Study
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Whole Food Plant Based Diet
Single-arm whole-food, plant-based diet will explore the effects on primary prevention in a free-range environment
Behavioral: whole food, plant based diet
whole food, plant based diet featuring vegetables, fruits, legumes, whole grains, seeds, and nuts




Primary Outcome Measures :
  1. Percent change in cholesterol specific biomarkers [ Time Frame: from baseline (study one visit) through 7 weeks of diet change ]
    o Percent change in LDL cholesterol, non-HDL cholesterol, and LDL particle concentration from baseline values


Secondary Outcome Measures :
  1. Percent change in cholesterol specific biomarkers [ Time Frame: from baseline (study one visit) through 7 weeks of diet change ]
    Percent change in triglyceride concentration

  2. Percent change in specific cholesterol biomarkers [ Time Frame: from baseline (study one visit) through 7 weeks of diet change ]
    Percent change in lipoprotein(a)

  3. Percent change in inflammatory biomarkers [ Time Frame: from baseline (study one visit) through 7 weeks of diet change ]
    Percent change in C-reactive protein

  4. Dietary behavioral modifications and adherence [ Time Frame: from baseline (study one visit) through 7 weeks of diet change ]
    Evaluation of changes made to diet and their respective adherence over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523247


Contacts
Contact: Cathleen C Forney, MBA, MEd. 717-544-1777 cforney2@lghealth.org

Locations
United States, Pennsylvania
Penn Medicine / Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Cathleen C Forney, MBA, MEd    717-544-1777    cforney2@lghealth.org   
Sponsors and Collaborators
Lancaster General Hospital
Louise von Hess Medical Research Institute
Investigators
Principal Investigator: Christopher Wenger, DO Penn Medicine/Lancaster General Health

Publications:
Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT03523247     History of Changes
Other Study ID Numbers: HYP2018_CW0001
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lancaster General Hospital:
Cholesterol
LDL
HDL
triglycerides
c-reactive protein
whole food diet
plant based diet
community based enrollment