Effect of Sucrose on Liver Fat
Effect of Eucaloric High and Low Sucrose Diets on Liver Fat in Healthy Adult Men With Liver Fat Levels Below 5%
1 other identifier
interventional
9
1 country
1
Brief Summary
AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5%
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started Jan 2014
Longer than P75 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
November 14, 2019
CompletedNovember 14, 2019
November 1, 2019
2.8 years
December 13, 2013
October 14, 2019
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change in Liver Fat
Liver fat was assessed by magnetic resonance spectrometry (MRS)
7 days
Secondary Outcomes (1)
Changes in Fasting Triglyceride Levels
Baseline and 7 days
Study Arms (2)
High sucrose diet
EXPERIMENTALHigh sucrose diet for 7 days
Low sucrose diet
EXPERIMENTALLow sucrose diet for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- Healthy men aged between 20 and 40 years with BMI between 20-25 kg/m2 and with normal liver fat levels (\<5%), normal fasting glucose (less than 5.5mmol/l) and HbA1C less than 5.7% will be eligible to volunteer.
You may not qualify if:
- Type 1 diabetes, Type 2 diabetes, hypertension or hyperlipidaemia
- Gained or lost ≥ 3kg weight in the past three months
- Use of medication likely to interfere with metabolism, appetite regulation, glucose homeostasis and hormonal balance
- Regular consumer of sugar sweetened beverages
- Any chronic illness
- Cardiovascular, hepatic or renal disease
- Excess alcohol intake (\>2 units per day)
- Exceeding UK minimum activity recommendation (30min moderate exercise 5d/wk)
- Current smokers (smoked within last 6 months)
- Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
- A history of drug or alcohol abuse in the last 2 years
- Pancreatitis
- Unable to have MRI (eg. metallic or magnetic implants, claustrophobia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIHR/Wellcome Trust Imperial Clinical Research Facility
London, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof Gary Frost
- Organization
- Imperial College London
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Frost
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2013
First Posted
December 19, 2013
Study Start
January 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 14, 2019
Results First Posted
November 14, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share