Cardiovascular Diseases
Conditions
Keywords
Platelet Aggregation
Brief summary
This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTPlacebo control
The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions
DIETARY_SUPPLEMENTLow dose pomace extract
Immediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
DIETARY_SUPPLEMENTHigh dose pomace extract
Immediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
Sponsors
University of Talca
Quadram Institute Bioscience
Centro de Estudios en Alimentos Procesados
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline platelet aggregation at three hours | Blood samples on two separate occasions (baseline and three hours post-intervention) |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline platelet aggregation at 5 days | Blood samples on two separate occasions (baseline and 5 days post- intervention) |
Countries
Chile
Outcome results
None listed