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
Scientific
The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Study design | Randomised cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/11/2007 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 - 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
The Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
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" |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
