Effect of Sucrose on Liver Fat

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT02015442
Collaborator
(none)
9
1
2
33
0.3

Study Details

Study Description

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%

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Sucrose
N/A

Detailed Description

DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4 week wash-out period. Dietary intervention will be based on iso-energetic substitution of sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy intake. Otherwise the macronutrient balance in both conditions will be based on UK average habitual intake.

POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of subjects to range from sedentary to a maximum of meeting the UK minimum activity recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2 units per day.

TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by completion of a 7-day food diary and be asked to wear an accelerometer armband to assess physical activity before each intervention week. Resting energy expenditure will also be assessed by indirect calorimetry.

7 day dietary interventions: Participants will be resident at the clinical research facility at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food will be provided at the facility. At the weekends, participants will have to leave the unit but food will be provided for those two days so that the diet can be continued at home.

At the start and end of each 7 day intervention: Weight, height and waist circumference will be taken; percentage liver fat and total and regional body composition will be measured by MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood pressure.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Effect of Eucaloric High and Low Sucrose Diets on Liver Fat in Healthy Adult Men With Liver Fat Levels Below 5%
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: High sucrose diet

High sucrose diet for 7 days

Dietary Supplement: Sucrose

Experimental: Low sucrose diet

Low sucrose diet for 7 days

Dietary Supplement: Sucrose

Outcome Measures

Primary Outcome Measures

  1. Percentage Change in Liver Fat [7 days]

    Liver fat was assessed by magnetic resonance spectrometry (MRS)

Secondary Outcome Measures

  1. Changes in Fasting Triglyceride Levels [Baseline and 7 days]

    Triglyceride levels assessed from plasma in fasting state

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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.

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 NIHR/Wellcome Trust Imperial Clinical Research Facility London United Kingdom

Sponsors and Collaborators

  • Imperial College London

Investigators

  • Principal Investigator: Gary Frost, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT02015442
Other Study ID Numbers:
  • SucroseLiver
First Posted:
Dec 19, 2013
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title High Sucrose Diet Then Low Sucrose Low Sucrose Diet Then High Sucrose
Arm/Group Description High sucrose diet for 7 days, then low sucrose diet Low sucrose diet for 7 days for first intervention, then high sucrose
Period Title: First Intervention (7 Days)
STARTED 5 4
COMPLETED 5 4
NOT COMPLETED 0 0
Period Title: First Intervention (7 Days)
STARTED 5 4
COMPLETED 5 4
NOT COMPLETED 0 0
Period Title: First Intervention (7 Days)
STARTED 5 4
COMPLETED 5 4
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title All Participants
Arm/Group Description All participants, cross-over study
Overall Participants 9
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
9
100%
>=65 years
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
24
(5)
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
9
100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom
9
100%

Outcome Measures

1. Primary Outcome
Title Percentage Change in Liver Fat
Description Liver fat was assessed by magnetic resonance spectrometry (MRS)
Time Frame 7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title High Sucrose Diet Low Sucrose Diet
Arm/Group Description High sucrose diet for 7 days Low sucrose diet for 7 days
Measure Participants 9 9
Mean (Standard Deviation) [percentage of change]
1.9
(1.7)
1.9
(1.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Sucrose Diet
Comments Baseline vs. treatment period
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.390
Comments
Method t-test, 2 sided
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Sucrose Diet
Comments Baseline vs treatment
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.204
Comments
Method t-test, 2 sided
Comments
2. Secondary Outcome
Title Changes in Fasting Triglyceride Levels
Description Triglyceride levels assessed from plasma in fasting state
Time Frame Baseline and 7 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title High Sucrose Diet Low Sucrose Diet
Arm/Group Description High sucrose diet for 7 days Low sucrose diet for 7 days
Measure Participants 9 9
Baseline
0.9
(0.1)
0.9
(0.4)
7 days
0.8
(0.3)
0.7
(0.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Sucrose Diet
Comments Baseline vs treatment
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.001
Comments calculated
Method t-test, 2 sided
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Sucrose Diet
Comments Baseline vs treatment
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.244
Comments
Method t-test, 2 sided
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection High Sucrose Diet, Low Sucrose Diet
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.244
Comments
Method ANOVA
Comments

Adverse Events

Time Frame 6 weeks
Adverse Event Reporting Description
Arm/Group Title High Sucrose Diet Low Sucrose Diet
Arm/Group Description High sucrose diet for 7 days Low sucrose diet for 7 days
All Cause Mortality
High Sucrose Diet Low Sucrose Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/9 (0%)
Serious Adverse Events
High Sucrose Diet Low Sucrose Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/9 (0%)
Other (Not Including Serious) Adverse Events
High Sucrose Diet Low Sucrose Diet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Prof Gary Frost
Organization Imperial College London
Phone 020 7594 0959
Email g.frost@imperial.ac.uk
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT02015442
Other Study ID Numbers:
  • SucroseLiver
First Posted:
Dec 19, 2013
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019