MedDataX Logo

Trial Outcomes & Findings for Glycemic Response Testing (NCT NCT01536860)

NCT ID: NCT01536860

Last Updated: 2013-11-27

Results Overview

The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

0-120 minutes

Results posted on

2013-11-27

Participant Flow

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.

This was a randomized double blind cross-over study. There was a wash out period of 3 or more days between interventions.

Participant milestones

Participant milestones
Measure
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.
First Intervention (1 Day)
STARTED
4
4
4
First Intervention (1 Day)
COMPLETED
4
4
4
First Intervention (1 Day)
NOT COMPLETED
0
0
0
Washout Period (3 Days)
STARTED
4
4
4
Washout Period (3 Days)
COMPLETED
3
4
4
Washout Period (3 Days)
NOT COMPLETED
1
0
0
Second Intervention (1 Day)
STARTED
4
4
4
Second Intervention (1 Day)
COMPLETED
4
4
4
Second Intervention (1 Day)
NOT COMPLETED
0
0
0
Third Intervention (1 Day)
STARTED
3
4
4
Third Intervention (1 Day)
COMPLETED
3
4
4
Third Intervention (1 Day)
NOT COMPLETED
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Washout Period (3 Days)
Lost to Follow-up
1
0
0

Baseline Characteristics

Glycemic Response Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=12 Participants
Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.
Age, Categorical
<=18 years
1 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=93 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
Sex: Female, Male
Female
7 Participants
n=93 Participants
Sex: Female, Male
Male
5 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 0-120 minutes

The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.

Outcome measures

Outcome measures
Measure
Control Test Drink
n=12 Participants
Control Drink Dietary Intervention : 300 ml of liquid food product
Experimental Test Drink 1
n=12 Participants
Control Drink containing ingredient 1 Dietary Intervention : 300 ml of liquid food product
Experimental Test Drink 2
n=11 Participants
Control Drink containing ingredient 2 Dietary Intervention : 300 ml of liquid food product
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
100 mmol*min/L
Standard Error 17
68 mmol*min/L
Standard Error 10
73 mmol*min/L
Standard Error 13

Adverse Events

Control Test Drink

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental Test Drink 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental Test Drink 2

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

Rungano Munyuki

RSSL

Phone: +44 118 918 4166

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place