How does dietary carbohydrate influence the formation of an atherogenic lipoprotein phenotype?

ISRCTN	ISRCTN09001687
DOI	https://doi.org/10.1186/ISRCTN09001687
ClinicalTrials.gov (NCT)	NCT01790984
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	6517
Sponsor	Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Funder	Biotechnology and Biological Sciences Research Council (BBSRC) (UK)

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 23/05/2022

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

Prof Bruce Griffin
Scientific

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

Study information

Primary study design	Interventional
Study design	Single-centre randomised interventional process of care trial
Secondary study design	Randomised controlled trial
Scientific title	How does dietary carbohydrate influence the formation of an atherogenic lipoprotein phenotype?
Study acronym	DRN 270 Carbohydrate and Lipoproteins
Study objectives	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(s)	MREC approved, ref: 08/H1109/227
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Formation of high- and low-risk lipoprotein phenotypes
Key secondary outcome measure(s)	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
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex
Target sample size at registration	36
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2009
Date of final enrolment	01/09/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Faculty of Health and Medical Science

Guildford
GU2 7XH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		27/05/2021	23/05/2022	No	No

Editorial Notes

23/05/2022: ClinicalTrials.gov results added.
10/09/2019: ClinicalTrials.gov number added.
20/04/2017: No publications found in PubMed, verifying study status with principal investigator.