How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?

NCT ID: NCT01790984

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-09-30

Brief Summary

The hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars on blood lipids will be more pronounced in people with a raised level of stored fat inside their liver, as compared to people with a low level of stored fat.

Detailed Description

This study aims to determine the metabolic mechanism(s) by which dietary extrinsic sugars (sucrose and fructose), promote the formation of a high risk dyslipidaemia, known as an atherogenic lipoprotein phenotype (raised plasma triglyceride, low HDL and predominance of small, dense LDL), in men with raised cardio-metabolic risk and percentage of liver fat, as determined by magnetic resonance spectroscopy (MRS). The study examined the impact of diets high and low in extrinsic sugars, on the metabolism of lipids and lipoproteins in vivo, of two groups of men with a high (>10%)and low (<2%)percentage of liver fat, by the trace-labelling of these lipid moieties with stable isotopes, and detection by gas chromatography mass spectrometry. The study had a two-way cross-over design, with two, 12 week dietary interventions separated by a six week wash-out period. The dietary intervention with high and low sugars was achieved by a dietary exchange with supermarket foods, which were consumed within the homes of the participants.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

High sugar low starch diet

A high sugar, low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with low sugar to starch content, with foods containing a high sugar to starch content to reach a target ratio of starch to sugar of 1:1.2

Group Type: EXPERIMENTAL

High sugar low starch diet

Intervention Type: OTHER

Low sugar high starch diet

Intervention Type: OTHER

Low sugar high starch diet

A high sugar, low starch diet was provided by the exchange of two thirds of the participants daily intake of carbohydrate. This was achieved by exchanging foods with a high sugar to starch content, with foods containing a low sugar to starch content to reach a target ratio of starch to sugar of 5:1

Group Type: EXPERIMENTAL

High sugar low starch diet

Intervention Type: OTHER

Low sugar high starch diet

Intervention Type: OTHER

Interventions

High sugar low starch diet

Intervention Type: OTHER

Low sugar high starch diet

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male gender,
• Increased cardio-metabolic risk ('RISCK' criteria Jebb et al (2010) Am J Clin Nutr 92, 748-758).
• Apo E3E3 genotype

Exclusion Criteria

• Any abnormal result in blood screen (renal and liver function, haematology)
• Diabetes
• Smoker
• Excessive alcohol consumption (>27units/week)
• Medication likely to affect lipid metabolism
• >3kg weight loss in preceding 3 months
• Any medical condition (eg. GI tract, allergies) affecting lipid metabolism or ability to comply with dietary interventions
• Involvement in any other study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: collaborator

Bruce A. Griffin

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Griffin

Professor of Nutritional Metabolism

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bruce A Griffin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Locations

University of Surrey

Guildford, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

BB/G009899/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RN0172 A/B

Identifier Type: -

Identifier Source: org_study_id