Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
14/08/2014
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

Prof Bruce Griffin

ORCID ID

Contact details

Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6517

Study information

Scientific title

Acronym

DRN 270 Carbohydrate and Lipoproteins

Study hypothesis

Despite the falling trend in death from cardiovascular disease (CVD) in the UK in the last 10 years, the morbidity in CVD is increasing exponentially as a direct result of the cardio-metabolic risk arising from obesity, metabolic syndrome and type 2 diabetes. One of the key public health nutritional strategies to prevent this from happening is to replace dietary fat, principally saturated fat, with carbohydrate, to reduce such risk factors as serum low density lipoprotein (LDL) cholesterol. However, meta-analyses have firmly established that replacing dietary fat with carbohydrate is not associated with a decrease in CVD risk. Moreover, when the amount and quality of carbohydrate is uncontrolled, an exchange of fat for carbohydrate can increase risk arising from the insulin-resistant conditions described above. Recent evidence suggests that this adverse effect of dietary carbohydrate on CVD risk can be ameliorated by controlling the quality of carbohydrate; this may be achieved by limiting intake of non-milk extrinsic sugars (fructose and sucrose) and increasing non-starch polysaccharides (NCP).

Ethics approval

MREC approved, ref: 08/H1109/227

Study design

Single-centre randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Other; Disease: Cardiovascular disease

Intervention

The study will be a randomised, dietary intervention with a cross-over design. It will examine the effect of two test diets for 12 weeks, that differ in the quality of carbohydrate (high and low non-milk extrinsic sugars [NMES]), in two groups of subjects at risk of metabolic syndrome but with different proportions of liver fat (low liver fat less than 2% and moderate liver fat greater than 10% but less than 20%). The test diets will be preceded by a 4-week run-in diet and separated by 4 weeks of wash-out.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Formation of high- and low-risk lipoprotein phenotypes

Secondary outcome measures

1. LDL kinetics, with a focus on the formation of small dense LDL
2. Sources of liver fat
3. Whether VLDL-TG is derived from increased DNL and/or systemically derived NEFA
4. VLDL kinetics, with focus on differential effects on the synthesis of VLDL-TG and VLDL-apoB

Overall trial start date

01/04/2009

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 36; UK sample size: 36

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2009

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

Biotechnology and Biological Sciences Research Council (BBSRC) (UK)

Sponsor details

Research & Development
Polaris House
Polaris Way
Swindon
SN2 1UH
United Kingdom

Sponsor type

Research council

Website

http://www.bbsrc.ac.uk/

Funders

Funder type

Research council

Funder name

Biotechnology and Biological Sciences Research Council (BBSRC) (UK)

Alternative name(s)

BBSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes