Trial Outcomes & Findings for Genetic-specific Effects of Fructose on Liver Lipogenesis (NCT NCT03783195)
NCT ID: NCT03783195
Last Updated: 2024-10-23
Results Overview
Elastography (Fibroscan) will be used to measure changes in liver fat.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
between week 0 (Baseline) and week 3
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
High Genetic Risk Score (GRS) Group
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
Low Genetic Risk Score (GRS) Group
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genetic-specific Effects of Fructose on Liver Lipogenesis
Baseline characteristics by cohort
| Measure |
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
26.88 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
24 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
25.53 years
STANDARD_DEVIATION 9.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Elastography (Fibroscan) will be used to measure changes in liver fat.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Liver Fat Content Based on Elastography
|
1.10 kilopascal (kPa)
Standard Deviation 3.2
|
-0.15 kilopascal (kPa)
Standard Deviation 0.85
|
PRIMARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Due to COVID-19 limitations, only 4 participants had both the Week 0 (Baseline) and Week 3 MRIs.
Magnetic resonance imaging (MRI) will be used to measure changes in liver fat (% change in fat fraction).
Outcome measures
| Measure |
Low GRS Group
n=3 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=1 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Percent Change in Liver Fat Content Based on MRI
|
-0.33 Percent fat fraction
Standard Deviation 2.3
|
-0.54 Percent fat fraction
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
VLDL-TG measurement in serum (mg/dl) at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG)
|
-0.007 mg/dl
Standard Deviation 0.03
|
-0.021 mg/dl
Standard Deviation 0.05
|
PRIMARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (mg\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG)
|
0.75 mg*hr/dl
Standard Deviation 0.31
|
0.66 mg*hr/dl
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Triglycerides
|
-2.14 mg/dl
Standard Deviation 29.9
|
21.75 mg/dl
Standard Deviation 60.6
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (mg\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Triglycerides
|
0.57 mg*hr/dl
Standard Deviation 0.35
|
0.59 mg*hr/dl
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting concentrations of serum HDL cholesterol (mg/dl) will be measured at week 0 and week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of HDL Cholesterol
|
0.39 mg/dl
Standard Deviation 20.7
|
-2.70 mg/dl
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: between week 0 (baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (mg\*hr/dl) of serum HDL cholesterol for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum HDL Cholesterol
|
0.66 mg*hr/dl
Standard Deviation 0.30
|
0.59 mg*hr/dl
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting concentrations of serum LDL cholesterol (mg/dl) will be measured.at week 0 and week 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of LDL Cholesterol
|
0.96 mg/dl
Standard Deviation 13.6
|
-4.40 mg/dl
Standard Deviation 36.2
|
SECONDARY outcome
Timeframe: Week 0 (baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (mg\*hr/dl) of serum LDL cholesterol for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum LDL Cholesterol
|
0.68 mg*hr/dl
Standard Deviation 0.25
|
0.63 mg*hr/dl
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting serum concentrations of total cholesterol (mg/dl) will be measured at week 0 and week 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Total Cholesterol
|
0.92 mg/dl
Standard Deviation 25.21
|
-2.77 mg/dl
Standard Deviation 53.2
|
SECONDARY outcome
Timeframe: week 0 and week 3Population: Adolescent and young adults of Caucasian descent.
Area under curve (AUC) (mg\*hr/dl) of serum total cholesterol for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Total Cholesterol
|
0.66 mg*hr/dl
Standard Deviation 0.27
|
0.63 mg*hr/dl
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting concentrations of serum uric acid (ng/ml) will be measured at week 0 and week 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Changes in Serum Concentrations of Uric Acid
|
-0.36 ng/ml
Standard Deviation 0.89
|
0.21 ng/ml
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (ng\*hr/ml) of serum uric acid for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Changes in AUC of Serum Uric Acid
|
0.52 ng*hr/ml
Standard Deviation 0.38
|
0.73 ng*hr/ml
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting concentrations of serum ALT (nmol) will be measured at week 0 and week 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT).
|
-0.007 nmol
Standard Deviation 0.03
|
-0.02 nmol
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (nmol/hr) of serum ALT for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Alanine Transaminase (ALT)
|
0.54 nmol/hr
Standard Deviation 0.42
|
0.66 nmol/hr
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Serum concentrations of serum AST will be measured at week 0 and week 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST).
|
1.28 IU/L
Standard Deviation 2.8
|
-1.91 IU/L
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (IU\*hr/L) of serum AST for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Aspartate Transaminase (AST).
|
0.73 IU*hr/L
Standard Deviation 0.17
|
0.61 IU*hr/L
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Fasting concentrations of serum ALP (nmol) will be measured at week 0 and week3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP)
|
-5.24 nmol
Standard Deviation 21.27
|
20.38 nmol
Standard Deviation 71.14
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (nmol/hr) of serum ALP for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Alkaline Phosphatase (ALP)
|
0.68 nmol/hr
Standard Deviation 0.16
|
0.63 nmol/hr
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Serum concentrations of GGT will be measured at week 0 and week 3
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT)
|
0.01 IU/L
Standard Deviation 0.04
|
0.26 IU/L
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: between week 0 (Baseline) and week 3Population: Adolescents and young adults of Caucasian descent
Area under curve (AUC) (IU\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
Outcome measures
| Measure |
Low GRS Group
n=7 Participants
This groups consists of individuals who are in the lowest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
High GRS Group
n=8 Participants
This group consists of individuals who are in the highest quartile of the genetic risk score (GRS) and will ingest one sugar drink (equal to 2 soft drinks) per day for 3 weeks. The GRS is computed by adding the number of alleles that increase the risk for liver lipogenesis or fatty liver.
Sugar drink: A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
|
|---|---|---|
|
Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT)
|
0.50 IU*hr/L
Standard Deviation 0.28
|
0.61 IU*hr/L
Standard Deviation 0.31
|
Adverse Events
High GRS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low GRS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Saroja Voruganti, PhD
University of North Carolina at Chapel Hill
Phone: 704-250-5009
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place