Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/12/2006
Date assigned
21/02/2007
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steven Hunter

ORCID ID

Contact details

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

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

http://www.royalhospitals.org/

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

  1. 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.

Additional files

Editorial Notes