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

NCT01790984 | Completed Results

• 2 other identifiers: RN0172 A/BBB/G009899/1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Keywords

Sugars, Fatty liver, Lipoprotein kinetics, Triglycerides

Outcome Measures

Primary Outcomes (2)

• Production Rate of VLDL-1 Triacylglycerol (TAG)

  The in vivo production rate of VLDL-1 TAG, trace-labelled with \[1,1,2,3,3-H5\] glycerol, measured in units of grams/day.

  After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14)

• Production Rate VLDL-1 Apoprotein B

  The in vivo production rate of VLDL-1 apoprotein B, trace-labelled with \[I-13C\] leucine (leucine with carbon-13), measured in units of milligrams/day.

  After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14)

Secondary Outcomes (4)

• Kinetics of Systemic Non-esterified Fatty Acids by [C-13]-Trace-labelled Palmitate

  After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14)

• De Novo Lipogenesis (Rate of Triacylglycerol (TAG) Synthesis in the Liver) as Measured by Contribution to VLDL-1 TAG Production Rate

  After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14)

• Intra-hepatocellular Lipid (IHCL) or % Liver Fat

  After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14)

• Plasma Concentration of Triacylglycerol

  After (post-diet) two 12 week diets (high sugar versus low sugar) in men with NAFLD (n=11) versus Controls (n=14)

Study Arms (2)

High sugar low starch diet

EXPERIMENTAL

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

Other: High sugar low starch diet; Other: Low sugar high starch diet

Low sugar high starch diet

EXPERIMENTAL

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

Other: High sugar low starch diet; Other: Low sugar high starch diet

Interventions

High sugar low starch diet OTHER

High sugar low starch diet; Low sugar high starch diet

Low sugar high starch diet OTHER

High sugar low starch diet; Low sugar high starch diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruce A. Griffin: lead
• Imperial College London: collaborator
• University of Cambridge: collaborator

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Limitations and Caveats

A limitation of metabolic studies is their small sample size, which is a consequence of the invasive nature, extent, labour intensity, and high cost ($850,000) of the metabolic investigations e.g. infusion/ingestion of 4 stable isotope tracers.

Results Point of Contact

• Title: Professor Bruce A.Griffin
• Organization: University of Surrey

b.griffin@surrey.ac.uk

+44 0483 689724

Study Officials

• Bruce A Griffin, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Nutritional Metabolism

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2012
• Last Updated: May 27, 2021
• Results First Posted: May 27, 2021

Record last verified: 2021-05

Locations

GB (1)