Low fat versus low carbohydrate weight reduction diets: evaluation of effects on insulin resistance and cardiovascular risk
| ISRCTN | ISRCTN85769730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85769730 |
| Protocol serial number | RGHT000222 |
| Sponsor | Royal Group of Hospitals (UK) |
| Funder | The Sugar Bureau (UK) |
- Submission date
- 07/12/2006
- Registration date
- 21/02/2007
- Last edited
- 03/09/2009
- 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
Regional Centre for Endocrinolgy and Diabetes
Level 1, Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | The study is a randomised, controlled intervention study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The traditional low fat/high carbohydrate diet has beneficial effects on factors linked to the risk of diabetes and atherosclerosis compared to a high fat/low carbohydrate diet. |
| Ethics approval(s) | Ethically approval has been granted by the Office for Research Ethics Committees in Northern Ireland (ORECNI) (ref: 05/NIR01/142). |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | The volunteers will be randomised to either a low fat or a low carbohydrate diet for eight weeks. All food for the duration of the diet will be provided. All assessments below will be carried out at baseline and again at the end of the diet. Insulin resistance will be assessed by the hyperinsulinaemic euglycaemic clamp. Body composition will be measured using Dexa scanning and bioelectrical impedence. Pulse wave analysis will be done to assess vascular compliance. A meal tolerence test will be done to measure pancreatic function. Subcutaneous adipose tissue samples will be collected to measure mRNA expression of hormones. Lipid profile, HBA1c, adipocykine levels and blood pressure will also be measured. |
| Intervention type | Other |
| Primary outcome measure(s) |
Assessment of insulin sensitivity by hyperinsulinaemic euglycaemic clamp |
| Key secondary outcome measure(s) |
1. Body weight and composition |
| Completion date | 31/07/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | 1. Male and female healthy volunteers 2. Aged 18 to 65 3. Body Mass Index (BMI) greater than 27 |
| Key exclusion criteria | 1. History of diabetes 2. coronary, hepatic or renal disease 3. Pregnancy |
| Date of first enrolment | 02/10/2005 |
| Date of final enrolment | 31/07/2007 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Regional Centre for Endocrinolgy and Diabetes
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/12/2009 | Yes | No |
