Trial Outcomes & Findings for Effect of Fibre Products on Appetite and Weight (NCT NCT00750438)
NCT ID: NCT00750438
Last Updated: 2019-11-19
Results Overview
The change in food intake following 24 weeks of supplementation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2019-11-19
Participant Flow
Non fermentable arm not conducted
Participant milestones
| Measure |
Inulin-control
Participants received inulin
|
Inulin-propionate Ester
Participants received inulin-propionate ester
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Inulin-control
Participants received inulin
|
Inulin-propionate Ester
Participants received inulin-propionate ester
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Effect of Fibre Products on Appetite and Weight
Baseline characteristics by cohort
| Measure |
Inulin-control
n=24 Participants
Participants received inulin
|
Inulin-propionate Ester
n=25 Participants
Participants received inulin-propionate ester
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
54 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
HbA1c
|
37.8 mmol/mol
STANDARD_DEVIATION 0.5 • n=5 Participants
|
38.2 mmol/mol
STANDARD_DEVIATION 0.7 • n=7 Participants
|
38 mmol/mol
STANDARD_DEVIATION 0.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksThe change in food intake following 24 weeks of supplementation
Outcome measures
| Measure |
Inulin-control
n=24 Participants
Participants received inulin
|
Inulin-propionate Ester
n=25 Participants
Participants received inulin-propionate ester
|
|---|---|---|
|
Appetite_Food Intake
Baseline
|
678 kcal
Interval 535.0 to 820.0
|
836 kcal
Interval 724.0 to 948.0
|
|
Appetite_Food Intake
24 weeks
|
645 kcal
Interval 514.0 to 776.0
|
763 kcal
Interval 654.0 to 872.0
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksBody weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Outcome measures
| Measure |
Inulin-control
n=24 Participants
Participants received inulin
|
Inulin-propionate Ester
n=25 Participants
Participants received inulin-propionate ester
|
|---|---|---|
|
Body Weight
Baseline
|
91 kg
Standard Error 2.8
|
88.5 kg
Standard Error 2.9
|
|
Body Weight
24 weeks
|
91.4 kg
Standard Error 3
|
87.5 kg
Standard Error 3
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksBody weight was measured in all subjects to the nearest 0.1 kg (Tanita BC-418MA) while subjects were wearing light clothing.
Outcome measures
| Measure |
Inulin-control
n=24 Participants
Participants received inulin
|
Inulin-propionate Ester
n=25 Participants
Participants received inulin-propionate ester
|
|---|---|---|
|
Body Weight - Number of Participants Gained ≥3% of Their Baseline Body Weight
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: MRS data could not be collected in 17 subjects, due to metal implants (n=8) and claustrophobia (n=9).
Body composition was assessed using MRI and MR spectroscopy (MRS), expressed as a percentage of total adipose tissue content.
Outcome measures
| Measure |
Inulin-control
n=15 Participants
Participants received inulin
|
Inulin-propionate Ester
n=17 Participants
Participants received inulin-propionate ester
|
|---|---|---|
|
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
Baseline
|
10.6 percentage of total adipose tissue
Standard Error 1.3
|
13.2 percentage of total adipose tissue
Standard Error 1.2
|
|
Adipose Tissue Distribution - Intra-abdominal Adipose Tissue
24 weeks
|
11.1 percentage of total adipose tissue
Standard Error 1.4
|
13.1 percentage of total adipose tissue
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 24 weeksThe homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function.
Outcome measures
| Measure |
Inulin-control
n=24 Participants
Participants received inulin
|
Inulin-propionate Ester
n=25 Participants
Participants received inulin-propionate ester
|
|---|---|---|
|
Insulin Sensitivity - HOMA IR
Baseline
|
2.7 percentage of Beta Cell Function
Standard Deviation 0.3
|
2 percentage of Beta Cell Function
Standard Deviation 0.2
|
|
Insulin Sensitivity - HOMA IR
24 weeks
|
2.3 percentage of Beta Cell Function
Standard Deviation 0.2
|
2 percentage of Beta Cell Function
Standard Deviation 0.2
|
Adverse Events
Inulin-control
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Inulin-propionate Ester
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inulin-control
n=31 participants at risk
Participants received inulin
|
Inulin-propionate Ester
n=29 participants at risk
Participants received inulin-propionate ester
|
|---|---|---|
|
Gastrointestinal disorders
Stomach discomfort
|
25.8%
8/31 • Number of events 8 • 24 weeks
|
3.4%
1/29 • Number of events 1 • 24 weeks
|
|
Gastrointestinal disorders
Bloating
|
25.8%
8/31 • Number of events 8 • 24 weeks
|
10.3%
3/29 • Number of events 3 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
45.2%
14/31 • Number of events 14 • 24 weeks
|
17.2%
5/29 • Number of events 5 • 24 weeks
|
|
Gastrointestinal disorders
Heartburns
|
9.7%
3/31 • Number of events 3 • 24 weeks
|
6.9%
2/29 • Number of events 2 • 24 weeks
|
|
Gastrointestinal disorders
Belching
|
6.5%
2/31 • Number of events 2 • 24 weeks
|
3.4%
1/29 • Number of events 1 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place