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

Not Applicable
Completed
Conditions
Hypercholesterolemia
Interventions
Other: Dietary Intervention
Registration Number
NCT03172611
Lead Sponsor
Texas Woman's University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Plant-based dietDietary InterventionA defined, plant-based diet was prescribed for 4 weeks.
Primary Outcome Measures
NameTimeMethod
Change in serum lipoprotein(a)Baseline and 4-weeks

Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks

Secondary Outcome Measures
NameTimeMethod
Change in serum total cholesterolBaseline and 4-weeks

Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks

Change in serum low-density lipoprotein cholesterolBaseline and 4-weeks

LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks

Change in serum high-density lipoprotein cholesterolBaseline and 4-weeks

Serum HDL (mg/dL) was documented at baseline and after 4-weeks

Change in serum high-density lipoprotein 2 cholesterolBaseline and 4-weeks

Serum HDL2-C (mg/dL) was documented at baseline and after 4-weeks

Change in serum apolipoprotein A-1Baseline and 4-weeks

Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks

Change in serum apolipoprotein-BBaseline and 4-weeks

Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks

Change in serum low-density lipoprotein particlesBaseline and 4-weeks

Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks

Change in serum small-dense low-density lipoprotein cholesterolBaseline and 4-weeks

Serum sdLDL-C (mg/dL) was documented at baseline and after 4-weeks

Trial Locations

Locations (1)

Montgomery Heart & Wellness

🇺🇸

Houston, Texas, United States

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