Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02986165
• Date of registration: 23/11/2016
• Prospective Registration: No
• Primary sponsor: Centro de Estudios en Alimentos Procesados
• Public title: Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation Tomasa
• Scientific title: Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation
• Date of first enrolment: September 2016
• Target sample size: 99
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02986165
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Ivan Palomo, Dr.
• Affiliation: University of Talca

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 26 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Intervention(s)

Dietary Supplement: High dose pomace extract

Dietary Supplement: Placebo control

Dietary Supplement: Low dose pomace extract

Primary Outcome(s)

Change from baseline platelet aggregation at three hours [Time Frame: Blood samples on two separate occasions (baseline and three hours post-intervention)]

Secondary Outcome(s)

Change from baseline platelet aggregation at 5 days [Time Frame: Blood samples on two separate occasions (baseline and 5 days post- intervention)]

Secondary ID(s)

R15F10012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Talca

Quadram Institute Bioscience