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

NCT ID: NCT03172611

Last Updated: 2017-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2017-03-15

Brief Summary

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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

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plant-based diet

A defined, plant-based diet was prescribed for 4 weeks.

Group Type EXPERIMENTAL

Dietary Intervention

Intervention Type OTHER

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

Interventions

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Dietary Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montgomery Heart & Wellness

UNKNOWN

Sponsor Role collaborator

Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Rami Najjar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rami Najjar, M.S.

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

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Montgomery Heart & Wellness

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 1837559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20815907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11288049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24871675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12221048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11590990 (View on PubMed)

Other Identifiers

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192790

Identifier Type: -

Identifier Source: org_study_id

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