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

NCT03523247 | Completed

• 1 other identifier: HYP2018_CW0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification; Cardiology

Keywords

Cholesterol; LDL; HDL; triglycerides; c-reactive protein; whole food diet; plant based diet; community based enrollment

Outcome Measures

Primary Outcomes (1)

• Percent change in cholesterol specific biomarkers

  Percent change in LDL cholesterol, non-HDL cholesterol, and LDL particle concentration from baseline values

  from baseline (study one visit) through 7 weeks of diet change

Secondary Outcomes (4)

• Percent change in cholesterol specific biomarkers

  from baseline (study one visit) through 7 weeks of diet change

• Percent change in specific cholesterol biomarkers

  from baseline (study one visit) through 7 weeks of diet change

• Percent change in inflammatory biomarkers

  from baseline (study one visit) through 7 weeks of diet change

• Dietary behavioral modifications and adherence

  from baseline (study one visit) through 7 weeks of diet change

Study Arms (1)

Whole Food Plant Based Diet

EXPERIMENTAL

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

Interventions

whole food, plant based diet BEHAVIORAL

whole food, plant based diet featuring vegetables, fruits, legumes, whole grains, seeds, and nuts

Whole Food Plant Based Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lancaster General Hospital: lead
• Louise von Hess Medical Research Institute: collaborator

Study Sites (1)

Penn Medicine / Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Related Publications (5)

• US Department of Health and Human Services. The surgeon general's call to action to prevent and decrease overweight and obesity. Rockville, MD: US Department of Health and Human Services, Public Health Service, Office of the Surgeon General; 2001 [cited 22 Jan 2013].

  BACKGROUND

• Reedy J, Krebs-Smith SM, Miller PE, Liese AD, Kahle LL, Park Y, Subar AF. Higher diet quality is associated with decreased risk of all-cause, cardiovascular disease, and cancer mortality among older adults. J Nutr. 2014 Jun;144(6):881-9. doi: 10.3945/jn.113.189407. Epub 2014 Feb 26.

  PMID: 24572039 BACKGROUND

• McCullough ML. Diet patterns and mortality: common threads and consistent results. J Nutr. 2014 Jun;144(6):795-6. doi: 10.3945/jn.114.192872. Epub 2014 Apr 9. No abstract available.

  PMID: 24717365 BACKGROUND

• Berkow SE, Barnard N. Vegetarian diets and weight status. Nutr Rev. 2006 Apr;64(4):175-88. doi: 10.1111/j.1753-4887.2006.tb00200.x.

  PMID: 16673753 BACKGROUND

• Farmer B, Larson BT, Fulgoni VL 3rd, Rainville AJ, Liepa GU. A vegetarian dietary pattern as a nutrient-dense approach to weight management: an analysis of the national health and nutrition examination survey 1999-2004. J Am Diet Assoc. 2011 Jun;111(6):819-27. doi: 10.1016/j.jada.2011.03.012.

  PMID: 21616194 BACKGROUND

MeSH Terms

Interventions

Diet, Plant-Based

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Christopher Wenger, DO

  Penn Medicine/Lancaster General Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: July 18, 2018
• Primary Completion: April 15, 2019
• Study Completion: December 31, 2019
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)