Comparison of 15% versus 5% sucrose intakes as part of a eucaloric diet in overweight/obese subjects: impact on insulin resistance, insulin secretion, postprandial glucose levels and vascular compliance

ISRCTN ISRCTN50808730
DOI https://doi.org/10.1186/ISRCTN50808730
Secondary identifying numbers RGHT000460
Submission date
31/10/2007
Registration date
21/02/2008
Last edited
28/06/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Steven Hunter
Scientific

The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Study information

Study designRandomised cross-over trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectives15% 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(s)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).
Health condition(s) or problem(s) studiedOverweight/obesity and risk of type 2 diabetes mellitus
InterventionEach 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Sucrose
Primary outcome measureInsulin resistance, assessed at the end of each six week dietary period using the euglycaemic hyperinsulinaemic glucose clamp technique.
Secondary outcome measures1. 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 study start date01/11/2007
Completion date01/08/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants12 - 15
Key inclusion criteria1. Healthy male and female volunteers
2. Overweight/obese (Body Mass Index [BMI] 25 - 35 kg/m^2)
3. Over 18 years old
Key exclusion criteria1. 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
Date of first enrolment01/11/2007
Date of final enrolment01/08/2009

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

The Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom

Sponsor information

Belfast Health and Social Care Trust (UK)
Hospital/treatment centre

(at the Royal Hospitals site)
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

Website http://www.belfasttrust.hscni.net/
ROR logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

Industry

The Sugar Bureau (UK)

No information available

Northern Ireland Research and Development Office (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 Yes No