Effects of Phytonutrients on Vascular Health

NCT02605850 | Completed

• 1 other identifier: IRB#15-001605
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will determine the effects of beneficial compounds of plant foods, such as pomegranate on cardiovascular health. This will be tested by asking healthy males to eat a high fat ground beef patty with pomegranate juice (PJ), pomegranate extract (PomX) or water and then measuring blood vessel dilation (endothelial function) by blood flow We also will measure the amount of Nitric Oxide (NO) in your blood and urine samples and sugar and insulin in blood. Healthy men have been chosen for this study because eating high fat hamburger patties can easily mimic in them the condition that causes atherosclerosis. The results from this study may help to explain how high fat foods can be harmful to the body and how beneficial plant foods can have on cardiovascular function

Conditions

Cardiovascular Diseases

Keywords

heart health

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Abnormal PAT Values That Are Related to Treatment

  The major outcomes are PAT changes after a test meal with and without pomegranate.

  Change from Baseline vascular function at 6 weeks

Secondary Outcomes (1)

• Number of Participants With Abnormal Laboratory Values That Are Related to Treatment

  Change from Baseline laboratory values at 6 weeks

Study Arms (3)

Ground beef patty + Water

PLACEBO COMPARATOR

32 healthy subjects, ages 18-35 years who meet all the eligibility criteria in the screening phase of the study will receive the ground beef patty + water to evaluate the clinical efficacy of pomegranate on vascular health.Then subjects will be randomized to consume pomegranate juice or extract. At visit 2, subjects will be tested before and after meal with pomegranate juice or extract, then take pomegranate product daily for 4 weeks. At visit 3, subjects will tested before and after test meal with pomegranate products.

Other: Water

Ground beef patty + Pomegranate Extract

ACTIVE COMPARATOR

32 healthy subjects, ages 18-35 years who meet all the eligibility criteria in the screening phase of the study will receive the ground beef patty + water to evaluate the clinical efficacy of pomegranate on vascular health.Then subjects will be randomized to consume pomegranate juice or extract. At visit 2, subjects will be tested before and after meal with pomegranate juice or extract, then take pomegranate product daily for 4 weeks. At visit 3, subjects will tested before and after test meal with pomegranate products.

Dietary Supplement: Pomegranate extract

Ground beef patty + Pomegranate Juice

ACTIVE COMPARATOR

32 healthy subjects, ages 18-35 years who meet all the eligibility criteria in the screening phase of the study will receive the ground beef patty + water to evaluate the clinical efficacy of pomegranate on vascular health.Then subjects will be randomized to consume pomegranate juice or extract. At visit 2, subjects will be tested before and after meal with pomegranate juice or extract, then take pomegranate product daily for 4 weeks. At visit 3, subjects will tested before and after test meal with pomegranate products.

Dietary Supplement: Pomegranate Juice

Interventions

Water OTHER

All subjects will consume ground beef patty meal with water at the baseline visit.

Ground beef patty + Water

Pomegranate Juice DIETARY_SUPPLEMENT

Pomegranate Juice will be taken 1/day for 4 weeks.

Also known as: PJ

Ground beef patty + Pomegranate Juice

Pomegranate extract DIETARY_SUPPLEMENT

Pomegranate extract will be taken 1/day for 4 weeks.

Also known as: PomX

Ground beef patty + Pomegranate Extract

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old males (inclusive)
• Non-smokers
• Must weigh a minimum of 110 pounds
• Willing to maintain normal activity and eating patterns for the duration of the study
• Willing to maintain their normal diet for the duration of the study but avoid pomegranate products and ellagitannin rich foods.

You may not qualify if:

• Any chronic medical conditions
• Abnormal liver function (AST and ALT \> 2 x upper limit)
• Currently taking steroidal drugs
• Cancer treated within the past two years
• Participation in a therapeutic research study within 30 days of baseline
• Use of antibiotics within one month
• Regular use of probiotics
• Allergy or sensitivity to pomegranate products
• Follow a vegetarian diet
• Known HIV positive

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (6)

• Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. doi: 10.1038/362801a0.

  PMID: 8479518 BACKGROUND

• Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction: a marker of atherosclerotic risk. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):168-75. doi: 10.1161/01.atv.0000051384.43104.fc.

  PMID: 12588755 BACKGROUND

• Kasprzak JD, Klosinska M, Drozdz J. Clinical aspects of assessment of endothelial function. Pharmacol Rep. 2006;58 Suppl:33-40.

  PMID: 17332669 BACKGROUND

• Anderson TJ, Gerhard MD, Meredith IT, Charbonneau F, Delagrange D, Creager MA, Selwyn AP, Ganz P. Systemic nature of endothelial dysfunction in atherosclerosis. Am J Cardiol. 1995 Feb 23;75(6):71B-74B. doi: 10.1016/0002-9149(95)80017-m.

  PMID: 7863979 BACKGROUND

• Nohria A, Gerhard-Herman M, Creager MA, Hurley S, Mitra D, Ganz P. Role of nitric oxide in the regulation of digital pulse volume amplitude in humans. J Appl Physiol (1985). 2006 Aug;101(2):545-8. doi: 10.1152/japplphysiol.01285.2005. Epub 2006 Apr 13.

  PMID: 16614356 BACKGROUND

• Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pumper GM, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol. 2003 May 21;41(10):1761-8. doi: 10.1016/s0735-1097(03)00329-2.

  PMID: 12767662 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Water; pomegranate fruit rind

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: November 16, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share