Trial Outcomes & Findings for A Study of Tomato Products and Disease Risk (NCT NCT00966550)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

6 hour postprandial study

Results posted on

2017-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Tomato First Then Non-tomato Tomato :High fat meal with tomato	Non-tomato First Then Tomato Non-tomato :High fat meal with non-tomato
Overall Study STARTED	13	12
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Tomato Products and Disease Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tomato First Then Non-tomato n=13 Participants tomato High fat test meal Tomato products: tomato with High fat test meal	Non-tomato First Then Tomato n=12 Participants Non-tomato high fat test meal Non-tomato test meal: non-tomato with High fat test meal	Total n=25 Participants Total of all reporting groups
Age, Continuous	24.9 years STANDARD_DEVIATION 5 • n=5 Participants	28.7 years STANDARD_DEVIATION 10.7 • n=7 Participants	27 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hour postprandial study

Population: Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.

Outcome measures

Outcome measures
Measure	Tomato n=25 Participants High fat tomato test meal Tomato products: High fat tomato test meal	Non-tomato n=25 Participants Non-tomato high fat test meal Non-tomato test meal: High fat non-tomato test meal
IL-6 Concentrations	2.2 pg/mL Standard Error 0.27	2.6 pg/mL Standard Error 0.28

Adverse Events

Tomato

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-tomato

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Britt Burton-Freeman

Illinois Institute of Technology

Phone: 312-567-5307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place