A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
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
Sites / Locations
- Montgomery Heart & Wellness
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plant-based diet
Arm Description
A defined, plant-based diet was prescribed for 4 weeks.
Outcomes
Primary Outcome Measures
Change in serum lipoprotein(a)
Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks
Secondary Outcome Measures
Change in serum total cholesterol
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in serum low-density lipoprotein cholesterol
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Change in serum high-density lipoprotein cholesterol
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Change in serum apolipoprotein-B
Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks
Change in serum low-density lipoprotein particles
Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks
Change in serum small-dense low-density lipoprotein cholesterol
Serum sdLDL-C (mg/dL) was documented at baseline and after 4-weeks
Change in serum high-density lipoprotein 2 cholesterol
Serum HDL2-C (mg/dL) was documented at baseline and after 4-weeks
Change in serum apolipoprotein A-1
Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks
Full Information
NCT ID
NCT03172611
First Posted
May 29, 2017
Last Updated
May 29, 2017
Sponsor
Texas Woman's University
Collaborators
Montgomery Heart & Wellness
1. Study Identification
Unique Protocol Identification Number
NCT03172611
Brief Title
A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
Official Title
A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
March 8, 2017 (Actual)
Study Completion Date
March 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
Collaborators
Montgomery Heart & Wellness
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plant-based diet
Arm Type
Experimental
Arm Description
A defined, plant-based diet was prescribed for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.
Primary Outcome Measure Information:
Title
Change in serum lipoprotein(a)
Description
Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Secondary Outcome Measure Information:
Title
Change in serum total cholesterol
Description
Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum low-density lipoprotein cholesterol
Description
LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum high-density lipoprotein cholesterol
Description
Serum HDL (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum apolipoprotein-B
Description
Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum low-density lipoprotein particles
Description
Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum small-dense low-density lipoprotein cholesterol
Description
Serum sdLDL-C (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum high-density lipoprotein 2 cholesterol
Description
Serum HDL2-C (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
Title
Change in serum apolipoprotein A-1
Description
Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks
Time Frame
Baseline and 4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami Najjar, M.S.
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montgomery Heart & Wellness
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1837559
Citation
Brown SA, Morrisett J, Patsch JR, Reeves R, Gotto AM Jr, Patsch W. Influence of short term dietary cholesterol and fat on human plasma Lp[a] and LDL levels. J Lipid Res. 1991 Aug;32(8):1281-9.
Results Reference
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PubMed Identifier
20815907
Citation
Bloomer RJ, Kabir MM, Canale RE, Trepanowski JF, Marshall KE, Farney TM, Hammond KG. Effect of a 21 day Daniel Fast on metabolic and cardiovascular disease risk factors in men and women. Lipids Health Dis. 2010 Sep 3;9:94. doi: 10.1186/1476-511X-9-94.
Results Reference
background
PubMed Identifier
11288049
Citation
Jenkins DJ, Kendall CW, Popovich DG, Vidgen E, Mehling CC, Vuksan V, Ransom TP, Rao AV, Rosenberg-Zand R, Tariq N, Corey P, Jones PJ, Raeini M, Story JA, Furumoto EJ, Illingworth DR, Pappu AS, Connelly PW. Effect of a very-high-fiber vegetable, fruit, and nut diet on serum lipids and colonic function. Metabolism. 2001 Apr;50(4):494-503. doi: 10.1053/meta.2001.21037.
Results Reference
background
PubMed Identifier
24871675
Citation
Le LT, Sabate J. Beyond meatless, the health effects of vegan diets: findings from the Adventist cohorts. Nutrients. 2014 May 27;6(6):2131-47. doi: 10.3390/nu6062131.
Results Reference
background
PubMed Identifier
12221048
Citation
Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 2002 Sep 10;106(11):1327-32. doi: 10.1161/01.cir.0000028421.91733.20.
Results Reference
background
PubMed Identifier
11590990
Citation
Kiortsis DN, Tzotzas T, Giral P, Bruckert E, Beucler I, Valsamides S, Turpin G. Changes in lipoprotein(a) levels and hormonal correlations during a weight reduction program. Nutr Metab Cardiovasc Dis. 2001 Jun;11(3):153-7.
Results Reference
background
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A Defined, Plant-based, 4-week Dietary Intervention Reduces Lp(a) and Other Atherogenic Particles
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