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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172611
• Other study ID #: 192790
• Status: Completed
• Phase: N/A
• First received: May 29, 2017
• Last updated: May 29, 2017
• Start date: January 3, 2017
• Est. completion date: March 15, 2017

Study information

• Verified date: May 2017
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 15, 2017
• Est. primary completion date: March 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Dietary Intervention
Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.

Locations

Country	Name	City	State
United States	Montgomery Heart & Wellness	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Woman's University	Montgomery Heart & Wellness

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Le LT, Sabaté 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum lipoprotein(a)	Serum Lp(a) (nmol/L) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum total cholesterol	Serum total cholesterol (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum low-density lipoprotein cholesterol	LDL cholesterol (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum high-density lipoprotein cholesterol	Serum HDL (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum apolipoprotein-B	Serum Apo-B (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	Change in serum low-density lipoprotein particles	Serum LDL-P (nmol/L) was documented at baseline and after 4-weeks	Baseline and 4-weeks
Secondary	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
Secondary	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
Secondary	Change in serum apolipoprotein A-1	Serum Apo A-1 (mg/dL) was documented at baseline and after 4-weeks	Baseline and 4-weeks