How does dietary carbohydrate influence the formation of an atherogenic lipoprotein phenotype?
| ISRCTN | ISRCTN09001687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09001687 |
| ClinicalTrials.gov number | NCT01790984 |
| Secondary identifying numbers | 6517 |
- 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
Scientific
Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom
Study information
| Study design | Single-centre randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2009 |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 36; UK sample size: 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
- England
- United Kingdom
Study participating centre
Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom
GU2 7XH
United Kingdom
Sponsor information
Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Research council
Research council
Research & Development
Polaris House
Polaris Way
Swindon
SN2 1UH
United Kingdom
| Website | http://www.bbsrc.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00cwqg982 |
Funders
Funder type
Research council
Biotechnology and Biological Sciences Research Council (BBSRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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.
