Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000460
Study information
Scientific title
Acronym
Study hypothesis
15% sucrose intake is detrimental to insulin action when compared to 5% sucrose intake as part of a eucaloric diet in overweight/obese individuals.
Ethics approval
Ethics approval received from the Regional Ethics Committee for Northern Ireland on the 30th October 2007 (ref: HSC REC 3 - REC number 07/NIR03/93).
Study design
Randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Overweight/obesity and risk of type 2 diabetes mellitus
Intervention
Each subject will undergo two dietary intervention periods, each six weeks long separated by a four week washout period. Both diets are matched for macronutrient profile and differ in their micronutrient profile, in that one will have 5% sucrose and the other 15% sucrose content.
Intervention type
Drug
Phase
Not Applicable
Drug names
Sucrose
Primary outcome measure
Insulin resistance, assessed at the end of each six week dietary period using the euglycaemic hyperinsulinaemic glucose clamp technique.
Secondary outcome measures
1. Glucose tolerance tests, performed at the beginning and end of each six week dietary period to assess postprandial glucose levels and insulin secretion
2. Plasma lipids
3. Vascular compliance; pulse wave analysis will be done at the beginning and end of each dietary period to assess vascular compliance
4. Glycaemic control
5. Blood pressure
Overall trial start date
01/11/2007
Overall trial end date
01/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy male and female volunteers
2. Overweight/obese (Body Mass Index [BMI] 25 - 35 kg/m^2)
3. Over 18 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 - 15
Participant exclusion criteria
1. A history of cardiac, hepatic or renal disease
2. Due to the use of radioisotopes, women of child bearing age will be excluded unless they are taking effective contraceptive precautions
Recruitment start date
01/11/2007
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
(at the Royal Hospitals site)
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
The Sugar Bureau (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Northern Ireland Research and Development Office (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23363580
Publication citations
-
Results
Lewis AS, McCourt HJ, Ennis CN, Bell PM, Courtney CH, McKinley MC, Young IS, Hunter SJ, Comparison of 5% versus 15% sucrose intakes as part of a eucaloric diet in overweight and obese subjects: effects on insulin sensitivity, glucose metabolism, vascular compliance, body composition and lipid profile. A randomised controlled trial., Metab. Clin. Exp., 2013, 62, 5, 694-702, doi: 10.1016/j.metabol.2012.11.008.