A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles

Study Overview
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Brief Summary
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This study evaluates the effects of consuming a defined, plant-based diet on lipoprotein(a) and other atherogenic particles associated with cardiovascular disease risk.

Detailed Description
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Lipoprotein(a) is a carrier of oxidized low-density lipoprotein and is a particularly atherogenic biomarker. Lp(a) has been previously documented to be resistant to dietary therapies and its concentration is thought to be determined by genes. A plant-based diet has not been previously used in an attempt to influence the concentration of Lp(a). Participants were instructed to follow a defined, plant-based dietary intervention for four weeks. All animal products were excluded. Cooked foods, free oils, soda, alcohol, and coffee were also to be excluded. All meals and snacks were provided to the participants for the full duration of the intervention. Emphasized were raw fruits and vegetables, while seeds, avocado, raw oats, raw buckwheat, and dehydrated foods were prepared as condiments. Vitamin, herbal, and mineral supplements were to be discontinued unless otherwise clinically indicated. Participants were not advised to alter their exercise habits. Serum biomarkers were obtained from participants at baseline and after 4-weeks.

Official Title
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A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Other: Dietary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index ≥25.0 kg/m^2 Serum low-density lipoprotein cholesterol concentration ≥100 Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 Exclusion Criteria: Tobacco use Drug abuse Excessive alcohol consumption (>2 glasses of wine or alcohol equivalent per day for men or >1 glass of wine or alcohol equivalent for woman) Current cancer diagnosis Estimated glomerular filtration rate <60 mg/dL Clinically defined infection Mental disability Hospitalization <6 months Previous exposure to plant-based diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant-based diet<br>A defined, plant-based diet was prescribed for 4 weeks. | Other: Dietary Intervention<br>* Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum lipoprotein(a) | Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum total cholesterol | Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum low-density lipoprotein cholesterol | LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum high-density lipoprotein cholesterol | Serum HDL (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum apolipoprotein-B | Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum low-density lipoprotein particles | Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum small-dense low-density lipoprotein cholesterol | Serum sdLDL-C (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum high-density lipoprotein 2 cholesterol | Serum HDL2-C (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks | 
| Change in serum apolipoprotein A-1 | Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks | Baseline and 4-weeks |