Tomato Supplementation and Cardiovascular Health

NCT03209817 | Completed

• 1 other identifier: HLS-JLG-03-07-17
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to test the effects of consuming two types of tomato (one ordinary cherry red tomato containing lycopene, and the other a yellow cherry tomato low in lycopene), on cardiovascular risk factors including endothelial function as the primary outcome, and blood lipids, inflammatory factors and blood pressure. In a crossover design, participants of this study will randomly consume 300g of raw cherry (red and yellow) tomatoes per day for four weeks, with a control period consuming no tomato products. Before and after each intervention, the cardiovascular outcomes mentioned above will be measured in the clinic.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Flow mediated dilation (FMD)

  To assess macrovascular endothelial function.

  at 4 weeks

• Laser doppler imaging (LDI)

  To assess the microvascular endothelial function.

  at 4 weeks

• Pulse wave velocity (PWV) and pulse wave analysis (PWA)

  To assess arterial stiffness

  at 4 weeks

Secondary Outcomes (4)

• Ambulatory blood pressure

  at 4 weeks

• Blood lipids

  at 4 weeks

• Interleukin-6 (IL-6)

  at 4 weeks

• C-reactive protein (CRP)

  at 4 weeks

Study Arms (3)

Red cherry tomato

EXPERIMENTAL

300 grams of red cherry tomatoes per day for four weeks (each)

Dietary Supplement: Red cherry tomato

Yellow cherry tomato

EXPERIMENTAL

300 grams of yellow cherry tomatoes per day for four weeks (each)

Dietary Supplement: Yellow cherry tomato

Control No tomato

NO INTERVENTION

No tomato products consumption

Interventions

Red cherry tomato DIETARY_SUPPLEMENT

300 grams of cherry tomatoes per day for four weeks (each)

Red cherry tomato

Yellow cherry tomato DIETARY_SUPPLEMENT

300 grams of cherry tomatoes per day for four weeks (each)

Yellow cherry tomato

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male.
• Aged between 18-60.
• Healthy.
• Non smoker.
• Not taking antioxidant supplement.
• No known allergy or intolerance to tomato.

You may not qualify if:

• Female
• Aged below 18 or above 60 years old.
• Suffering and taking medications for hypertension (\>140/90mmHg), diabetes, high blood cholesterol and heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome).
• Taking antioxidant supplements.
• Smoking.
• Allergy to tomato or tomato products.

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

Related Publications (1)

• Cheng HM, Koutsidis G, Lodge JK, Ashor A, Siervo M, Lara J. Tomato and lycopene supplementation and cardiovascular risk factors: A systematic review and meta-analysis. Atherosclerosis. 2017 Feb;257:100-108. doi: 10.1016/j.atherosclerosis.2017.01.009. Epub 2017 Jan 13.

  PMID: 28129549 BACKGROUND

Study Officials

• Jose Lara, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 6, 2017
• Study Start: January 23, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)