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
Secondary identifying numbers RGHT000222
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

Regional Centre for Endocrinolgy and Diabetes
Level 1, Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom

Study information

Study designThe study is a randomised, controlled intervention study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific title
Study objectivesThe 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) studiedObesity
InterventionThe 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 typeOther
Primary outcome measureAssessment of insulin sensitivity by hyperinsulinaemic euglycaemic clamp
Secondary outcome measures1. Body weight and composition
2. Assessment of blood pressure
3. Lipids
4. Vascular compliance
5. Adiopcykine levels
6. Pancreatic funtion
Overall study start date02/10/2005
Completion date31/07/2007

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants24 volunteers
Key inclusion criteria1. Male and female healthy volunteers
2. Aged 18 to 65
3. Body Mass Index (BMI) greater than 27
Key exclusion criteria1. History of diabetes
2. coronary, hepatic or renal disease
3. Pregnancy
Date of first enrolment02/10/2005
Date of final enrolment31/07/2007

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Regional Centre for Endocrinolgy and Diabetes
Belfast
BT12 6BA
United Kingdom

Sponsor information

Royal Group of Hospitals (UK)
Hospital/treatment centre

Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

Website http://www.royalhospitals.org/
ROR logo "ROR" https://ror.org/03rq50d77

Funders

Funder type

Industry

The Sugar Bureau (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 01/12/2009 Yes No