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Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes

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ClinicalTrials.gov Identifier: NCT01696773
Recruitment Status : Active, not recruiting
First Posted : October 1, 2012
Results First Posted : October 24, 2014
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Cooperstone, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Carotenoid and Flavonoid Absorption
Interventions Other: Tangerine tomato juice
Other: Red tomato juice
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tangerine Tomato Juice First, Then Red Tomato Juice Red Tomato Juice First, Then Tangerine Tomato Juice
Hide Arm/Group Description Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
Period Title: Days 1-13, Washout
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Day 14, First Intervention
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Days 15-27, Washout
Started 6 6
Completed 5 6
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Day 28, Second Intervention
Started 5 6
Completed 5 6
Not Completed 0 0
Arm/Group Title Tangerine Tomato Juice First, Then Red Tomato Juice Red Tomato Juice First, Then Tangerine Tomato Juice Total
Hide Arm/Group Description Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28 Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28 Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
22.8  (2.8) 29.0  (13.4) 25.9  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
3
  50.0%
3
  50.0%
6
  50.0%
Male
3
  50.0%
3
  50.0%
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 6 participants 12 participants
23.1  (1.4) 25.5  (1.6) 23.3  (1.4)
Plasma cholesterol (mg/dL)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 6 participants 6 participants 12 participants
170.6  (8.9) 176.2  (12.5) 173.8  (10.6)
Plasma triglycerides (mg/dL)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 6 participants 6 participants 12 participants
65.8  (49.3) 85.8  (42.3) 75.8  (45.0)
Hematocrit  
Mean (Standard Deviation)
Unit of measure:  Volume % of red blood cells in blood
Number Analyzed 6 participants 6 participants 12 participants
41.8  (2.8) 42.0  (3.8) 41.9  (3.2)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 6 participants 6 participants 12 participants
13.9  (0.8) 14.1  (1.1) 14.0  (1.1)
1.Primary Outcome
Title Pharmacokinetics of Carotenoid Absorption
Hide Description 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.
Time Frame 11 post-prandial blood samples will be taken over 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tangerine Tomato Juice Red Tomato Juice
Hide Arm/Group Description:

Tangerine tomato juice will be fed

Tangerine tomato juice: Post-prandial feeding study

Red tomato juice will be fed

Red tomato juice: Post-prandial feeding study

Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: nmol*h/L
690.9  (117.8) 81.6  (32.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tangerine Tomato Juice Red Tomato Juice
Hide Arm/Group Description

Tangerine tomato juice will be fed

Tangerine tomato juice: Post-prandial feeding study

Red tomato juice will be fed

Red tomato juice: Post-prandial feeding study

All-Cause Mortality
Tangerine Tomato Juice Red Tomato Juice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tangerine Tomato Juice Red Tomato Juice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tangerine Tomato Juice Red Tomato Juice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/11 (0.00%)    
Reproductive system and breast disorders     
Menstrual distress [1]  1/12 (8.33%)  1 0/11 (0.00%)  0
[1]
1 subject chose to dropout of the study 4 days after the first day long visit (at day 18). Adverse event categorized as sexual/reproductive function – other, menstrual distress – mild to moderate, not attributable or associated with the study agent.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven J. Schwartz
Organization: The Ohio State University
Phone: 614-292-2934
EMail: schwartz.177@osu.edu
Layout table for additonal information
Responsible Party: Jessica Cooperstone, Ohio State University
ClinicalTrials.gov Identifier: NCT01696773     History of Changes
Other Study ID Numbers: 2012H0189
First Submitted: September 27, 2012
First Posted: October 1, 2012
Results First Submitted: October 14, 2014
Results First Posted: October 24, 2014
Last Update Posted: September 11, 2019