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

B

Bruce A. Griffin

Status

Completed

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01790984
RN0172 A/B
BB/G009899/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

27 participants in 2 patient groups

High sugar low starch diet
Experimental group
Description:
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
Treatment:
Other: Low sugar high starch diet
Other: High sugar low starch diet
Low sugar high starch diet
Experimental group
Description:
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
Treatment:
Other: Low sugar high starch diet
Other: High sugar low starch diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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