Trial Outcomes & Findings for Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes (NCT NCT01696773)
NCT ID: NCT01696773
Last Updated: 2025-10-20
Results Overview
The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.
ACTIVE_NOT_RECRUITING
NA
12 participants
11 post-prandial blood samples will be taken over 12 hours
2025-10-20
Participant Flow
Participant milestones
| Measure |
Tangerine Tomato Juice First, Then Red Tomato Juice
Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
|
Red Tomato Juice First, Then Tangerine Tomato Juice
Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
|
|---|---|---|
|
Days 1-13, Washout
STARTED
|
6
|
6
|
|
Days 1-13, Washout
COMPLETED
|
6
|
6
|
|
Days 1-13, Washout
NOT COMPLETED
|
0
|
0
|
|
Day 14, First Intervention
STARTED
|
6
|
6
|
|
Day 14, First Intervention
COMPLETED
|
6
|
6
|
|
Day 14, First Intervention
NOT COMPLETED
|
0
|
0
|
|
Days 15-27, Washout
STARTED
|
6
|
6
|
|
Days 15-27, Washout
COMPLETED
|
5
|
6
|
|
Days 15-27, Washout
NOT COMPLETED
|
1
|
0
|
|
Day 28, Second Intervention
STARTED
|
5
|
6
|
|
Day 28, Second Intervention
COMPLETED
|
5
|
6
|
|
Day 28, Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tangerine Tomato Juice First, Then Red Tomato Juice
Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
|
Red Tomato Juice First, Then Tangerine Tomato Juice
Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
|
|---|---|---|
|
Days 15-27, Washout
Adverse Event
|
1
|
0
|
Baseline Characteristics
Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes
Baseline characteristics by cohort
| Measure |
Tangerine Tomato Juice First, Then Red Tomato Juice
n=6 Participants
Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28
|
Red Tomato Juice First, Then Tangerine Tomato Juice
n=6 Participants
Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.8 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
25.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
BMI
|
23.1 kg/m^2
STANDARD_DEVIATION 1.4 • n=5 Participants
|
25.5 kg/m^2
STANDARD_DEVIATION 1.6 • n=7 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Plasma cholesterol (mg/dL)
|
170.6 mg/dL
STANDARD_DEVIATION 8.9 • n=5 Participants
|
176.2 mg/dL
STANDARD_DEVIATION 12.5 • n=7 Participants
|
173.8 mg/dL
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Plasma triglycerides (mg/dL)
|
65.8 mg/dL
STANDARD_DEVIATION 49.3 • n=5 Participants
|
85.8 mg/dL
STANDARD_DEVIATION 42.3 • n=7 Participants
|
75.8 mg/dL
STANDARD_DEVIATION 45.0 • n=5 Participants
|
|
Hematocrit
|
41.8 Volume % of red blood cells in blood
STANDARD_DEVIATION 2.8 • n=5 Participants
|
42.0 Volume % of red blood cells in blood
STANDARD_DEVIATION 3.8 • n=7 Participants
|
41.9 Volume % of red blood cells in blood
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Hemoglobin
|
13.9 g/dL
STANDARD_DEVIATION 0.8 • n=5 Participants
|
14.1 g/dL
STANDARD_DEVIATION 1.1 • n=7 Participants
|
14.0 g/dL
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 11 post-prandial blood samples will be taken over 12 hoursThe primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.
Outcome measures
| Measure |
Tangerine Tomato Juice
n=11 Participants
Tangerine tomato juice will be fed
Tangerine tomato juice: Post-prandial feeding study
|
Red Tomato Juice
n=11 Participants
Red tomato juice will be fed
Red tomato juice: Post-prandial feeding study
|
|---|---|---|
|
Pharmacokinetics of Carotenoid Absorption
|
690.9 nmol*h/L
Standard Error 117.8
|
81.6 nmol*h/L
Standard Error 32.1
|
Adverse Events
Tangerine Tomato Juice
Red Tomato Juice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tangerine Tomato Juice
n=12 participants at risk
Tangerine tomato juice will be fed
Tangerine tomato juice: Post-prandial feeding study
|
Red Tomato Juice
n=11 participants at risk
Red tomato juice will be fed
Red tomato juice: Post-prandial feeding study
|
|---|---|---|
|
Reproductive system and breast disorders
Menstrual distress
|
8.3%
1/12 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place