Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000222
Study information
Scientific title
Acronym
Study hypothesis
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
Ethically approval has been granted by the Office for Research Ethics Committees in Northern Ireland (ORECNI) (ref: 05/NIR01/142).
Study design
The study is a randomised, controlled intervention study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Assessment of insulin sensitivity by hyperinsulinaemic euglycaemic clamp
Secondary outcome measures
1. Body weight and composition
2. Assessment of blood pressure
3. Lipids
4. Vascular compliance
5. Adiopcykine levels
6. Pancreatic funtion
Overall trial start date
02/10/2005
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female healthy volunteers
2. Aged 18 to 65
3. Body Mass Index (BMI) greater than 27
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
24 volunteers
Participant exclusion criteria
1. History of diabetes
2. coronary, hepatic or renal disease
3. Pregnancy
Recruitment start date
02/10/2005
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Regional Centre for Endocrinolgy and Diabetes
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Royal Group of Hospitals (UK)
Sponsor details
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
The Sugar Bureau (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
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19720791
Publication citations
-
Results
Bradley U, Spence M, Courtney CH, McKinley MC, Ennis CN, McCance DR, McEneny J, Bell PM, Young IS, Hunter SJ, Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance, and cardiovascular risk: a randomized control trial., Diabetes, 2009, 58, 12, 2741-2748, doi: 10.2337/db09-0098.