Trial Outcomes & Findings for Effect of Fermentable Carbohydrate on Glucose Homeostasis (NCT NCT01841073)

NCT ID: NCT01841073

Last Updated: 2019-11-25

Results Overview

An oral glucose tolerance test (OGTT) using 75 g of glucose was performed to clarify glycaemic status.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: 9 weeks
• Results posted on: 2019-11-25

Participant Flow

Participant milestones

Measure	Inulin Inulin intervention	Cellulose Cellulose intervention
Overall Study STARTED	22	22
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Inulin Inulin intervention	Cellulose Cellulose intervention
Overall Study Adverse Event	1	1
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Inulin n=20 Participants Participant received inulin	Cellulose n=19 Participants Participants received cellulose	Total n=39 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 12 • n=20 Participants	59.7 years STANDARD_DEVIATION 8.9 • n=19 Participants	58.95 years STANDARD_DEVIATION 10 • n=39 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	9 Participants n=19 Participants	17 Participants n=39 Participants
Sex: Female, Male Male	12 Participants n=20 Participants	10 Participants n=19 Participants	22 Participants n=39 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	20 participants n=20 Participants	19 participants n=19 Participants	39 participants n=39 Participants
Weight	88.2 kg STANDARD_DEVIATION 14 • n=20 Participants	83.4 kg STANDARD_DEVIATION 19.7 • n=19 Participants	85.8 kg STANDARD_DEVIATION 16.8 • n=39 Participants
BMI	30.8 kg/m^2 STANDARD_DEVIATION 4.1 • n=20 Participants	30 kg/m^2 STANDARD_DEVIATION 2.3 • n=19 Participants	30.4 kg/m^2 STANDARD_DEVIATION 3.2 • n=39 Participants
Haemoglobin A1c	5.9 mmol/mol STANDARD_DEVIATION 0.1 • n=20 Participants	5.7 mmol/mol STANDARD_DEVIATION 0.1 • n=19 Participants	5.8 mmol/mol STANDARD_DEVIATION 0.1 • n=39 Participants

PRIMARY outcome

Timeframe: 9 weeks

An oral glucose tolerance test (OGTT) using 75 g of glucose was performed to clarify glycaemic status.

Outcome measures

Measure	Inulin n=20 Participants Received Inulin intervention	Cellulose n=19 Participants Received Cellulose intervention
Glycaemic Control	-0.23 mmol//l Standard Error 0.17	0.44 mmol//l Standard Error 0.24

SECONDARY outcome

Timeframe: 9 weeks

Food intake following intervention over 9 weeks compared to baseline and between the two group

Outcome measures

Measure	Inulin n=20 Participants Received Inulin intervention	Cellulose n=19 Participants Received Cellulose intervention
Food Intake in Gram at 9 Weeks	-127 g Standard Error 45.4	-0.47 g Standard Error 22.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 weeks

Change in body weight over 9 week intervention

Outcome measures

Measure	Inulin n=20 Participants Received Inulin intervention	Cellulose n=20 Participants Received Cellulose intervention
Percentage Change in Body Weight	-5.3 percentage change Standard Error 0.1	-4.3 percentage change Standard Error 0.4

Adverse Events

Inulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cellulose

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

Prof Gary Frost

Imperial College London

Phone: +44 (0)20 7594 0959

Email: g.frost@imperial.ac.uk

Results disclosure agreements

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