Trial Outcomes & Findings for Effect of Sucrose on Liver Fat (NCT NCT02015442)

NCT ID: NCT02015442

Last Updated: 2019-11-14

Results Overview

Liver fat was assessed by magnetic resonance spectrometry (MRS)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2019-11-14

Participant Flow

Participant milestones

Measure	High Sucrose Diet Then Low Sucrose High sucrose diet for 7 days, then low sucrose diet	Low Sucrose Diet Then High Sucrose Low sucrose diet for 7 days for first intervention, then high sucrose
First Intervention (7 Days) STARTED	5	4
First Intervention (7 Days) COMPLETED	5	4
First Intervention (7 Days) NOT COMPLETED	0	0
Wash-out (4 Weeks) STARTED	5	4
Wash-out (4 Weeks) COMPLETED	5	4
Wash-out (4 Weeks) NOT COMPLETED	0	0
Second Intervention (7 Days) STARTED	5	4
Second Intervention (7 Days) COMPLETED	5	4
Second Intervention (7 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Participants n=9 Participants All participants, cross-over study
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Age, Continuous	24 years STANDARD_DEVIATION 5 • n=9 Participants
Sex: Female, Male Female	0 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants
Region of Enrollment United Kingdom	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 7 days

Liver fat was assessed by magnetic resonance spectrometry (MRS)

Outcome measures

Measure	High Sucrose Diet n=9 Participants High sucrose diet for 7 days	Low Sucrose Diet n=9 Participants Low sucrose diet for 7 days
Percentage Change in Liver Fat	1.9 percentage of change Standard Deviation 1.7	1.9 percentage of change Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline and 7 days

Triglyceride levels assessed from plasma in fasting state

Outcome measures

Measure	High Sucrose Diet n=9 Participants High sucrose diet for 7 days	Low Sucrose Diet n=9 Participants Low sucrose diet for 7 days
Changes in Fasting Triglyceride Levels Baseline	0.9 mmol/l Standard Deviation 0.1	0.9 mmol/l Standard Deviation 0.4
Changes in Fasting Triglyceride Levels 7 days	0.8 mmol/l Standard Deviation 0.3	0.7 mmol/l Standard Deviation 0.3

Adverse Events

High Sucrose Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Sucrose Diet

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: 020 7594 0959

Email: g.frost@imperial.ac.uk

Results disclosure agreements

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