Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/10/2007
Date assigned
21/02/2008
Last edited
28/06/2013
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

The Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGHT000460

Study information

Scientific title

Acronym

Study hypothesis

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

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).

Study design

Randomised cross-over trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Sucrose

Primary outcome measures

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 trial start date

01/11/2007

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12 - 15

Participant 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

Recruitment start date

01/11/2007

Recruitment end date

01/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

(at the Royal Hospitals site)
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Sponsor type

Government

Website

http://www.belfasttrust.hscni.net/

Funders

Funder type

Industry

Funder name

The Sugar Bureau (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Northern Ireland Research and Development Office (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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23363580

Publication citations

  1. Results

    Lewis AS, McCourt HJ, Ennis CN, Bell PM, Courtney CH, McKinley MC, Young IS, Hunter SJ, Comparison of 5% versus 15% sucrose intakes as part of a eucaloric diet in overweight and obese subjects: effects on insulin sensitivity, glucose metabolism, vascular compliance, body composition and lipid profile. A randomised controlled trial., Metab. Clin. Exp., 2013, 62, 5, 694-702, doi: 10.1016/j.metabol.2012.11.008.

Additional files

Editorial Notes