Glycemic Response Testing

This study has been completed.
Sponsor:
Collaborator:
Reading Scientific Services Ltd.
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01536860
First received: February 16, 2012
Last updated: November 5, 2013
Last verified: November 2013
Results First Received: September 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Conditions: Glycemic Index
Glycemic Response
Intervention: Other: Dietary Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 11 subjects completed the study. The study was conducted at one clinical research site and study started February, 2012 and was completed in March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a randomized double blind cross-over study. There was a wash out period of 3 or more days between interventions.

Reporting Groups
  Description
Control Test Drink/Exp Test Drink 1/Exp Test Drink 2

Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.

Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period

Exp Test Drink 1/Control Test Drink/Exp Test Drink 2

Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.

Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.

Consume Exp Test Drink 2 once over a 15 minute period.

Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1

Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.

Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.

Consume Exp Test Drink 1 once over a 15 minute period.


Participant Flow for 5 periods

Period 1:   First Intervention (1 Day)
    Control Test Drink/Exp Test Drink 1/Exp Test Drink 2     Exp Test Drink 1/Control Test Drink/Exp Test Drink 2     Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1  
STARTED     4     4     4  
COMPLETED     4     4     4  
NOT COMPLETED     0     0     0  

Period 2:   Washout Period (3 Days)
    Control Test Drink/Exp Test Drink 1/Exp Test Drink 2     Exp Test Drink 1/Control Test Drink/Exp Test Drink 2     Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1  
STARTED     4     4     4  
COMPLETED     4     4     4  
NOT COMPLETED     0     0     0  

Period 3:   Second Intervention (1 Day)
    Control Test Drink/Exp Test Drink 1/Exp Test Drink 2     Exp Test Drink 1/Control Test Drink/Exp Test Drink 2     Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1  
STARTED     4     4     4  
COMPLETED     4     4     4  
NOT COMPLETED     0     0     0  

Period 4:   Washout Period (3 Days)
    Control Test Drink/Exp Test Drink 1/Exp Test Drink 2     Exp Test Drink 1/Control Test Drink/Exp Test Drink 2     Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1  
STARTED     4     4     4  
COMPLETED     3     4     4  
NOT COMPLETED     1     0     0  
Lost to Follow-up                 1                 0                 0  

Period 5:   Third Intervention (1 Day)
    Control Test Drink/Exp Test Drink 1/Exp Test Drink 2     Exp Test Drink 1/Control Test Drink/Exp Test Drink 2     Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1  
STARTED     3     4     4  
COMPLETED     3     4     4  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     7  
Male     5  



  Outcome Measures

1.  Primary:   Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products   [ Time Frame: 0-120 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rungano Munyuki
Organization: RSSL
phone: +44 118 918 4166
e-mail: rungano.munyuki@rssl.com


No publications provided


Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01536860     History of Changes
Other Study ID Numbers: P12-00794
Study First Received: February 16, 2012
Results First Received: September 11, 2012
Last Updated: November 5, 2013
Health Authority: United Kingdom: Research Ethics Committee