Trial Outcomes & Findings for Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers (NCT NCT02701270)
NCT ID: NCT02701270
Last Updated: 2016-07-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose
Results posted on
2016-07-27
Participant Flow
Volunteers were recruited through the Study site (Leatherhead Food Research, UK) volunteer database in September - October 2015.
13 healthy volunteers were recruited, 12 volunteers were screened and one excluded (did not meet inclusion criteria).
Participant milestones
| Measure |
Polydextrose First, Then Dextrose, Fibre1 and 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 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.
|
Dextrose First, Then Fibre1, Fibre 2 and Polydextrose
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.
|
Fibre1 First, Then Fibre 2, Polydextrose and Dextrose
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.
|
Fibre 2 First, Then Polydextrose, Dextrose and Fibre1
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.
|
|---|---|---|---|---|
|
First Intervention at Visit 1
STARTED
|
2
|
3
|
3
|
3
|
|
First Intervention at Visit 1
COMPLETED
|
2
|
3
|
3
|
3
|
|
First Intervention at Visit 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention at Visit 2
STARTED
|
2
|
3
|
3
|
3
|
|
Second Intervention at Visit 2
COMPLETED
|
2
|
3
|
3
|
3
|
|
Second Intervention at Visit 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention at Visit 3
STARTED
|
2
|
3
|
3
|
3
|
|
Third Intervention at Visit 3
COMPLETED
|
2
|
3
|
3
|
3
|
|
Third Intervention at Visit 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Fourth Intervention at Visit 4
STARTED
|
2
|
3
|
3
|
3
|
|
Fourth Intervention at Visit 4
COMPLETED
|
2
|
3
|
3
|
3
|
|
Fourth Intervention at Visit 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.09 years
STANDARD_DEVIATION 2.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
|
Body Mass Index
|
23.8 kg/m^2
STANDARD_DEVIATION 0.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dosePopulation: Participants from whom full set of blood glucose measurements were available.
Outcome measures
| Measure |
Experimental Dietary Fibre 1
n=11 Participants
Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
|
Experimental Dietary Fibre 2
n=11 Participants
Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
|
Polydextrose Control
n=11 Participants
Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
|
Dextrose Control
n=11 Participants
Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
|
|---|---|---|---|---|
|
Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response
|
127.45 min*mmol/L
Standard Deviation 52.24
|
143.53 min*mmol/L
Standard Deviation 52.11
|
19.27 min*mmol/L
Standard Deviation 8.03
|
134.21 min*mmol/L
Standard Deviation 59.00
|
SECONDARY outcome
Timeframe: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dosePopulation: Participants from whom full set of blood insulin measurements were available.
Outcome measures
| Measure |
Experimental Dietary Fibre 1
n=9 Participants
Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
|
Experimental Dietary Fibre 2
n=9 Participants
Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
|
Polydextrose Control
n=9 Participants
Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
|
Dextrose Control
n=9 Participants
Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
|
|---|---|---|---|---|
|
Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response
|
595.49 min*mmol/L
Standard Deviation 151.72
|
640.94 min*mmol/L
Standard Deviation 286.52
|
63.37 min*mmol/L
Standard Deviation 55.81
|
687.13 min*mmol/L
Standard Deviation 257.67
|
Adverse Events
Experimental Dietary Fibre 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental Dietary Fibre 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Polydextrose Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dextrose Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Dietary Fibre 1
n=11 participants at risk
Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
|
Experimental Dietary Fibre 2
n=11 participants at risk
Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
|
Polydextrose Control
n=11 participants at risk
Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
|
Dextrose Control
n=11 participants at risk
Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
0.00%
0/11
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI cannot release information without the sponsor's approval.
- Publication restrictions are in place
Restriction type: OTHER