NCT03172611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 29, 2017

Last Update Submit

May 29, 2017

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Change in serum lipoprotein(a)

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

    Baseline and 4-weeks

Secondary Outcomes (8)

  • Change in serum total cholesterol

    Baseline and 4-weeks

  • Change in serum low-density lipoprotein cholesterol

    Baseline and 4-weeks

  • Change in serum high-density lipoprotein cholesterol

    Baseline and 4-weeks

  • Change in serum apolipoprotein-B

    Baseline and 4-weeks

  • Change in serum low-density lipoprotein particles

    Baseline and 4-weeks

  • +3 more secondary outcomes

Study Arms (1)

Plant-based diet

EXPERIMENTAL

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

Other: Dietary Intervention

Interventions

Dietary InterventionOTHER

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

Plant-based diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montgomery Heart & Wellness

Houston, Texas, 77025, United States

Location

Related Publications (6)

  • 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.

    PMID: 1837559BACKGROUND

  • 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.

    PMID: 20815907BACKGROUND

  • 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.

    PMID: 11288049BACKGROUND

  • 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.

    PMID: 24871675BACKGROUND

  • 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.

    PMID: 12221048BACKGROUND

  • 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.

    PMID: 11590990BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Rami Najjar, M.S.

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

January 3, 2017

Primary Completion

March 8, 2017

Study Completion

March 15, 2017

Last Updated

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)