N/A Completed N=27 Randomized Basic Science

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

non-alcoholic fatty liver disease (NAFLD)

Source: ClinicalTrials.gov NCT01790984 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcomePrimary: Production Rate of VLDL-1 Triacylglycerol (TAG) — 20.9; 18.9; 16.6; 12.4 grams/day — p=<0.05

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Production Rate of VLDL-1 Triacylglycerol (TAG)	20.9; 18.9; 16.6; 12.4	<0.05 sig
PRIMARY Production Rate VLDL-1 Apoprotein B	481; 492; 546; 414	<0.05 sig
SECONDARY Kinetics of Systemic Non-esterified Fatty Acids by [C-13]-Trace-labelled Palmitate	169; 147; 168; 168	<0.05 sig
SECONDARY De Novo Lipogenesis (Rate of Triacylglycerol (TAG) Synthesis in the Liver) as Measured by Contribution to VLDL-1 TAG Production Rate	1.66; 1.59; 1.32; 0.56	<0.05 sig
SECONDARY Intra-hepatocellular Lipid (IHCL) or % Liver Fat	24.2; 14.2; 3.6; 1.5	>0.05
SECONDARY Plasma Concentration of Triacylglycerol	2.05; 1.77; 1.33; 1.13	<0.05 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01790984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.