NCT03783195

Genetic-specific Effects of Fructose on Liver Lipogenesis

Completed NA Results posted Last updated 23 October 2024

What this trial tests

NA trial testing Sugar drink in NAFLD in 15 participants. Completed in 25 April 2023.

Timeline

25 January 2019

Primary endpoint
25 April 2023

25 April 2023

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	15
Start date	25 January 2019
Primary completion	25 April 2023
Estimated completion	25 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Sugar drink

Conditions studied

• NAFLD — all drugs for NAFLD →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 12 to 40, any sex, with NAFLD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Liver Fat Content Based on Elastography Primary · between week 0 (Baseline) and week 3

Elastography (Fibroscan) will be used to measure changes in liver fat.

Group	Value	95% CI
High GRS Group	-0.15	± 0.85
Low GRS Group	1.10	± 3.2

Mean Percent Change in Liver Fat Content Based on MRI Primary · between week 0 (Baseline) and week 3

Magnetic resonance imaging (MRI) will be used to measure changes in liver fat (% change in fat fraction).

Group	Value	95% CI
High GRS Group	-0.54	± 0.00
Low GRS Group	-0.33	± 2.3

Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG) Primary · between week 0 (Baseline) and week 3

VLDL-TG measurement in serum (mg/dl) at week 0 and Week 3.

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	-0.021	± 0.05
Low Genetic Risk Score (GRS) Group	-0.007	± 0.03

Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG) Primary · between week 0 (Baseline) and week 3

Area under curve (AUC) (mg\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	0.66	± 0.35
Low Genetic Risk Score (GRS) Group	0.75	± 0.31

Mean Change in Serum Concentrations of Triglycerides Secondary · between week 0 (Baseline) and week 3

Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	21.75	± 60.6
Low Genetic Risk Score (GRS) Group	-2.14	± 29.9

Mean Change in AUC of Serum Triglycerides Secondary · between week 0 (Baseline) and week 3

Area under curve (AUC) (mg\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	0.59	± 0.27
Low Genetic Risk Score (GRS) Group	0.57	± 0.35

Mean Change in Serum Concentrations of HDL Cholesterol Secondary · between week 0 (Baseline) and week 3

Fasting concentrations of serum HDL cholesterol (mg/dl) will be measured at week 0 and week 3.

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	-2.70	± 15.9
Low Genetic Risk Score (GRS) Group	0.39	± 20.7

Mean Change in AUC of Serum HDL Cholesterol Secondary · between week 0 (baseline) and week 3

Area under curve (AUC) (mg\*hr/dl) of serum HDL cholesterol for baseline and 3hr time points at week 0 and Week 3.

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	0.59	± 0.30
Low Genetic Risk Score (GRS) Group	0.66	± 0.30

Mean Change in Serum Concentrations of LDL Cholesterol Secondary · between week 0 (Baseline) and week 3

Fasting concentrations of serum LDL cholesterol (mg/dl) will be measured.at week 0 and week 3

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	-4.40	± 36.2
Low Genetic Risk Score (GRS) Group	0.96	± 13.6

Mean Change in AUC of Serum LDL Cholesterol Secondary · Week 0 (baseline) and week 3

Area under curve (AUC) (mg\*hr/dl) of serum LDL cholesterol for baseline and 3hr time points at week 0 and Week 3.

Group	Value	95% CI
High GRS Group	0.63	± 0.27
Low GRS Group	0.68	± 0.25

Mean Change in Serum Concentrations of Total Cholesterol Secondary · between week 0 (Baseline) and week 3

Fasting serum concentrations of total cholesterol (mg/dl) will be measured at week 0 and week 3

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	-2.77	± 53.2
Low Genetic Risk Score (GRS) Group	0.92	± 25.21

Mean Change in AUC of Serum Total Cholesterol Secondary · week 0 and week 3

Area under curve (AUC) (mg\*hr/dl) of serum total cholesterol for baseline and 3hr time points at week 0 and Week 3.

Group	Value	95% CI
High Genetic Risk Score (GRS) Group	0.63	± 0.27
Low Genetic Risk Score (GRS) Group	0.66	± 0.27

Sponsor's own description

The primary goal of this study is to identify a set of genotypes that increase the risk for nonalcoholic fatty liver disease (NAFLD) and predispose individuals to increased de novo lipogenesis (DNL) and liver fat accumulation when exposed to fructose intake. The proposed goal will be achieved through the completion of following aims:

1. To determine the impact of prolonged exposure of fructose on hepatic lipid accumulation in Caucasian individuals with high and low genetic risk for NAFLD,
2. to determine the impact of acute exposure of fructose on hepatic DNL, and
3. to determine the relationship between markers of DNL, liver fat accumulation and serum concentrations of lipids, uric acid and liver function markers before and after the fructose challenge.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. NAFLD-related SNPs are linked to changes in liver fat, as measured by the CAP score, and serum lipids in response to a 3-week sugar-sweetened beverage intervention: a pilot study.
   Jeyaraj FT, Vennam SS, Nelson K, Watts K, et al · · 2026 · PMID 41810674 · DOI 10.1039/d5fo03248b