Trial Outcomes & Findings for Colonic Propionate, Appetite, and Weight Loss (NCT NCT03322514)

NCT ID: NCT03322514

Last Updated: 2019-11-20

Results Overview

The weight assessed by a body scale

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2019-11-20

Participant Flow

Participant milestones

Measure	Experimental Group 10 g of Inulin-Propionate Esters will be administered per day Inulin-Propionate Esters: Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora.	Inulin 10 g of Inulin will be administered per day Inulin: Inulin
Overall Study STARTED	6	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Experimental Group 10 g of Inulin-Propionate Esters will be administered per day Inulin-Propionate Esters: Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora.	Inulin 10 g of Inulin will be administered per day Inulin: Inulin
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Experimental Group n=6 Participants 10 g of Inulin-Propionate Esters will be administered per day Inulin-Propionate Esters: Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora.	Inulin n=6 Participants 10 g of Inulin will be administered per day Inulin: Inulin	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants	6 Participants n=6 Participants	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=12 Participants
Age, Continuous	30.6 years STANDARD_DEVIATION 5.9 • n=6 Participants	35.2 years STANDARD_DEVIATION 12.1 • n=6 Participants	33.4 years STANDARD_DEVIATION 8.9 • n=12 Participants
Sex: Female, Male Female	4 Participants n=6 Participants	5 Participants n=6 Participants	9 Participants n=12 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	6 participants n=6 Participants	6 participants n=6 Participants	12 participants n=12 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

The weight assessed by a body scale

Outcome measures

Measure	Experimental Group n=5 Participants 10 g of Inulin-Propionate Esters administered per day	Inulin n=5 Participants 10 g of Inulin administered per day
Change in Weight Loss Compared to Baseline	-2.6 kg Standard Error 0.9	-3 kg Standard Error 1.04

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Experimental Group n=5 Participants 10 g of Inulin-Propionate Esters administered per day	Inulin n=5 Participants 10 g of Inulin administered per day
Glucose Blood Level Baseline to 12 Weeks 12 weeks	5.1 mmol/L Standard Error 0.1	4.8 mmol/L Standard Error 0.1
Glucose Blood Level Baseline to 12 Weeks Baseline	4.9 mmol/L Standard Error 0.1	4.4 mmol/L Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Measure	Experimental Group n=5 Participants 10 g of Inulin-Propionate Esters administered per day	Inulin n=5 Participants 10 g of Inulin administered per day
Insulin Level in Serum Baseline	50.4 mU/mL Standard Error 10.8	48.9 mU/mL Standard Error 18.3
Insulin Level in Serum 12 weeks	41.0 mU/mL Standard Error 6.7	46.0 mU/mL Standard Error 21.1

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inulin

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