Diet ModificationWholeLIFENCT03523247
A Whole Food Plant Diet and Its Lipidemic Effects on Primary Prevention in a Free-range Population
A study testing whole food, plant based diet in people with Diet Modification and Cardiology, run by Lancaster General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet Modification, Cardiology
- What is being tested?
- whole food, plant based diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any condition that, in the opinion of the patient's healthcare provider, will adversely affect study execution or data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine / Lancaster General Hospital
Lancaster, Pennsylvania, 17602
About this study
Official title: A Whole Food, Plant Based Diet and Its Lipidemic Effects on Primary Prevention Population in a Free-range Environment - a Pilot Study
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.
Read the 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.
- Conditions
- Diet Modification, Cardiology
- Being tested
- whole food, plant based diet
- Keywords
- Cholesterol, LDL, HDL, triglycerides, c-reactive protein, whole food diet, plant based diet, community based enrollment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole food, plant based dietBehavioural
whole food, plant based diet featuring vegetables, fruits, legumes, whole grains, seeds, and nuts
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: whole food, plant based diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in cholesterol specific biomarkers
Percent change in LDL cholesterol, non-HDL cholesterol, and LDL particle concentration from baseline values
Measured: from baseline (study one visit) through 7 weeks of diet change
Secondary outcomes (4)
Percent change in cholesterol specific biomarkers
Percent change in triglyceride concentration
Measured: from baseline (study one visit) through 7 weeks of diet change
Percent change in specific cholesterol biomarkers
Percent change in lipoprotein(a)
Measured: from baseline (study one visit) through 7 weeks of diet change
Percent change in inflammatory biomarkers
Percent change in C-reactive protein
Measured: from baseline (study one visit) through 7 weeks of diet change
Dietary behavioral modifications and adherence
Evaluation of changes made to diet and their respective adherence over time
Measured: from baseline (study one visit) through 7 weeks of diet change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start18 Jul 2018
- Primary completion15 Apr 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Louise von Hess Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Christopher Wenger, DO, Principal investigator, Penn Medicine/Lancaster General Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523247
- Sponsor's protocol ID
- HYP2018_CW0001
- Acronym
- WholeLIFE
- Status last verified
- Feb 2024
- First submitted
- 1 May 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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].
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.
PubMed 24572039McCullough 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.
PubMed 24717365Berkow 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.
PubMed 16673753Farmer 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.
PubMed 21616194
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Whole Food, Plant Based Diet and Its Lipidemic Effects on Primary Prevention Population in a Free-range Environment - a Pilot Study
- ClinicalTrials.gov ID
- NCT03523247
- Acronym / sponsor ID
- WholeLIFE / HYP2018_CW0001
- Conditions
- Diet Modification, Cardiology
- Keywords
- Cholesterol, LDL, HDL, triglycerides, c-reactive protein, whole food diet, plant based diet, community based enrollment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Collaborators
- Louise von Hess Medical Research Institute
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Food Plant Based Diet | Experimental | Behavioral: whole food, plant based dietSingle-arm whole-food, plant-based diet will explore the effects on primary prevention in a free-range environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any condition that, in the opinion of the patient's healthcare provider, will adversely affect study execution or data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole food, plant based dietwhole food, plant based diet featuring vegetables, fruits, legumes, whole grains, seeds, and nuts | Behavioural | Whole Food Plant Based Diet |
Primary outcome
Percent change in cholesterol specific biomarkers
Time frame: from baseline (study one visit) through 7 weeks of diet change
Percent change in LDL cholesterol, non-HDL cholesterol, and LDL particle concentration from baseline values
4 secondary outcomes
Percent change in cholesterol specific biomarkers
Time frame: from baseline (study one visit) through 7 weeks of diet change
Percent change in specific cholesterol biomarkers
Time frame: from baseline (study one visit) through 7 weeks of diet change
Percent change in inflammatory biomarkers
Time frame: from baseline (study one visit) through 7 weeks of diet change
Dietary behavioral modifications and adherence
Time frame: from baseline (study one visit) through 7 weeks of diet change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- BackgroundUS 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: PubMed 24572039Reedy 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.
- Background: PubMed 24717365McCullough 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.
- Background: PubMed 16673753Berkow 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.
- Background: PubMed 21616194Farmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Wenger, DO principal investigator
Penn Medicine/Lancaster General Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole food, plant based diet in people with Diet Modification and Cardiology, run by Lancaster General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in cholesterol specific biomarkers (time frame: from baseline (study one visit) through 7 weeks of diet change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523247, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.