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OpenTrials
Completed

NCT Number: NCT03172611

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montgomery Heart & Wellness

Houston, Texas, 77025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Intervention

Other

Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.

Primary outcomes

  1. Change in serum lipoprotein(a)

    Time frame: Baseline and 4-weeks

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

Secondary outcomes

  1. Change in serum total cholesterol

    Time frame: Baseline and 4-weeks

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

  2. Change in serum low-density lipoprotein cholesterol

    Time frame: Baseline and 4-weeks

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

  3. Change in serum high-density lipoprotein cholesterol

    Time frame: Baseline and 4-weeks

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

  4. Change in serum apolipoprotein-B

    Time frame: Baseline and 4-weeks

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

  5. Change in serum low-density lipoprotein particles

    Time frame: Baseline and 4-weeks

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

  6. Change in serum small-dense low-density lipoprotein cholesterol

    Time frame: Baseline and 4-weeks

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

  7. Change in serum high-density lipoprotein 2 cholesterol

    Time frame: Baseline and 4-weeks

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

  8. Change in serum apolipoprotein A-1

    Time frame: Baseline and 4-weeks

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

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Collaborators

  • Montgomery Heart & Wellness

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 1, 2017
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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