Hypercholesterolemia
Conditions
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.
Interventions
OTHERDietary Intervention
Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.
Sponsors
Montgomery Heart & Wellness
Texas Woman's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum lipoprotein(a) | Baseline and 4-weeks | Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum total cholesterol | Baseline and 4-weeks | Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum low-density lipoprotein cholesterol | Baseline and 4-weeks | LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum high-density lipoprotein cholesterol | Baseline and 4-weeks | Serum HDL (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum apolipoprotein-B | Baseline and 4-weeks | Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum low-density lipoprotein particles | Baseline and 4-weeks | Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks |
| Change in serum small-dense low-density lipoprotein cholesterol | Baseline and 4-weeks | Serum sdLDL-C (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum high-density lipoprotein 2 cholesterol | Baseline and 4-weeks | Serum HDL2-C (mg/dL) was documented at baseline and after 4-weeks |
| Change in serum apolipoprotein A-1 | Baseline and 4-weeks | Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks |
Countries
United States
Outcome results
None listed