N/A
N=27
How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?
Non-alcoholic Fatty Liver Disease (NAFLD)
Bottom Line
View on ClinicalTrials.gov: NCT01790984 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Production Rate of VLDL-1 Triacylglycerol (TAG) — 20.9; 18.9; 16.6; 12.4 grams/day — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High sugar low starch diet (Other); Low sugar high starch diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bruce A. Griffin
- Primary completion
- Aug 2011
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 |
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.
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
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.