Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation (Tomasa)

C

Centro de Estudios en Alimentos Procesados

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Dietary Supplement: Placebo control
Dietary Supplement: High dose pomace extract
Dietary Supplement: Low dose pomace extract

Study type

Interventional

Funder types

Other

Identifiers

NCT02986165
R15F10012

Details and patient eligibility

About

This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.

Full description

Evidence from human intervention trials and mechanistic studies suggests that tomato and tomato based products are associated with a reduction in CVD risk. The mechanism by which this protective effect occurs is not clearly understood but research has focused on its potential to modulate platelet function. This single-blind, randomized, parallel design human intervention trial will recruit 99 participants to consume an orange flavoured beverage containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over a 5-day period. The study aims is to investigate the effects of consuming different doses of the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato pomace extracts was tested prior starting this study by undertaking a single ascending dose study.

Enrollment

99 patients

Sex

Male

Ages

18 to 26 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Apparently healthy men aged between 18 and 26 years
  • BMI >19.5 and <26.0
  • Platelet aggregation response corresponding to ≥ 65%

Exclusion criteria

  • Known tomato allergy
  • Chronic medical conditions requiring active treatment (e.g. cardiovascular disease, diabetes, asthma)
  • Gastro-intestinal disease/disorders
  • Smokers
  • Medically prescribed medication known to affect platelet function
  • Self-prescribed medication known to affect platelet function (e.g. aspirin and non-steroidal anti-inflammatory drugs) unless participant is willing to give up.
  • Bleeding disorders (e.g. haemophilia)
  • Dietary supplements judged to affect study outcome
  • Parallel participation in another research project which involves dietary intervention
  • Blood donation within 16 weeks prior to the study
  • Depressed or elevated blood pressure measurements (<90/50 or 95/50 if symptomatic or ≥ 160/100 mmHg)
  • Any person related to or living with any member of the study team

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

99 participants in 3 patient groups, including a placebo group

Placebo control
Placebo Comparator group
Description:
100 g of flavoured water
Treatment:
Dietary Supplement: Placebo control
Low dose pomace extract
Experimental group
Description:
1 g pomace extract powder
Treatment:
Dietary Supplement: Low dose pomace extract
High dose pomace extract
Experimental group
Description:
2.5 g pomace extract powder
Treatment:
Dietary Supplement: High dose pomace extract

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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