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Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02701270
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Danisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant)
Condition Healthy Volunteers
Interventions Dietary Supplement: Experimental Dietary Fibre 1
Dietary Supplement: Experimental Dietary Fibre 2
Dietary Supplement: Polydextrose
Dietary Supplement: Dextrose
Enrollment 13
Recruitment Details Volunteers were recruited through the Study site (Leatherhead Food Research, UK) volunteer database in September - October 2015.
Pre-assignment Details 13 healthy volunteers were recruited, 12 volunteers were screened and one excluded (did not meet inclusion criteria).
Arm/Group Title Polydextrose First, Then Dextrose, Fibre1 and Fibre 2 Dextrose First, Then Fibre1, Fibre 2 and Polydextrose Fibre1 First, Then Fibre 2, Polydextrose and Dextrose Fibre 2 First, Then Polydextrose, Dextrose and Fibre1
Hide Arm/Group Description Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2. Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control. Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control. Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1.
Period Title: First Intervention at Visit 1
Started 2 3 3 3
Completed 2 3 3 3
Not Completed 0 0 0 0
Period Title: Second Intervention at Visit 2
Started 2 3 3 3
Completed 2 3 3 3
Not Completed 0 0 0 0
Period Title: Third Intervention at Visit 3
Started 2 3 3 3
Completed 2 3 3 3
Not Completed 0 0 0 0
Period Title: Fourth Intervention at Visit 4
Started 2 3 3 3
Completed 2 3 3 3
Not Completed 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
44.09  (2.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
11
  91.7%
Male
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 12 participants
12
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants
23.8  (0.62)
1.Primary Outcome
Title Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
Hide Description [Not Specified]
Time Frame 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from whom full set of blood glucose measurements were available.
Arm/Group Title Experimental Dietary Fibre 1 Experimental Dietary Fibre 2 Polydextrose Control Dextrose Control
Hide Arm/Group Description:
Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
Overall Number of Participants Analyzed 11 11 11 11
Mean (Standard Deviation)
Unit of Measure: min*mmol/L
127.45  (52.24) 143.53  (52.11) 19.27  (8.03) 134.21  (59.00)
2.Secondary Outcome
Title Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response
Hide Description [Not Specified]
Time Frame 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from whom full set of blood insulin measurements were available.
Arm/Group Title Experimental Dietary Fibre 1 Experimental Dietary Fibre 2 Polydextrose Dextrose Control
Hide Arm/Group Description:
Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
Overall Number of Participants Analyzed 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: min*mmol/L
595.49  (151.72) 640.94  (286.52) 63.37  (55.81) 687.13  (257.67)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Dietary Fibre 1 Experimental Dietary Fibre 2 Polydextrose Control Dextrose Control
Hide Arm/Group Description Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally. Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally. Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally. Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
All-Cause Mortality
Experimental Dietary Fibre 1 Experimental Dietary Fibre 2 Polydextrose Control Dextrose Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Dietary Fibre 1 Experimental Dietary Fibre 2 Polydextrose Control Dextrose Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)      0/11 (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 0%
Experimental Dietary Fibre 1 Experimental Dietary Fibre 2 Polydextrose Control Dextrose Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/11 (18.18%)      2/11 (18.18%)      0/11 (0.00%)      0/11 (0.00%)    
Nervous system disorders         
Headache *  2/11 (18.18%)  2 2/11 (18.18%)  2 0/11 (0.00%)  0 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
PI cannot release information without the sponsor's approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kirsti Tiihonen
Organization: Danisco Sweeteners Oy
Phone: +358 10 431 050
EMail: kirsti.tiihonen@dupont.com
Layout table for additonal information
Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT02701270     History of Changes
Other Study ID Numbers: 111031-DP-2015-06-26
First Submitted: February 25, 2016
First Posted: March 8, 2016
Results First Submitted: April 12, 2016
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016