NAFLD
Conditions
Keywords
Glucose, Fructose, Fatty-liver, Polymorphisms, Imaging, Fibroscan
Brief summary
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.
Detailed description
BACKGROUND AND RATIONALE Non-alcoholic fatty liver disease (NAFLD) is characterized by fat accumulation in liver cells not caused by alcohol. A leading cause of chronic liver disease in the US, NAFLD represents a group of disorders including steatosis, nonalcoholic steatohepatitis with fibrosis. It has substantially risen in prevalence over the last two decades with the estimated prevalence being 20% among US adults and 25% in young adults (18-39 years). Over 64 million individuals are believed to have NAFLD with annual medical costs rising to more $100 billion. More common in individuals who are obese or diabetic and/or have metabolic syndrome, NAFLD has been associated with increased cirrhosis, liver-related mortality and hepatocellular carcinoma. Both genetic and environmental, including nutritional, factors contribute to the onset and progression of NAFLD. Increased consumption of sugar-sweetened, fructose-rich beverages has been linked to NAFLD. Fructose, commonly found in soft drinks, fruit juices and energy drinks, affects many metabolic processes, foremost being an increase in fat accumulation in the liver and hence, NAFLD. Genome-wide and candidate gene studies have identified several genes associated with NAFLD. However, none of these studies have shown the cumulative effects of single nucleotide polymorphisms (SNPs) on changes in liver fat when exposed to fructose. The results from this study can be extrapolated to larger cohorts and other ethnicities and are therefore, expected to lay the foundation for developing personalized nutritional plans.
Interventions
OTHERSugar 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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants are assigned to high genetic risk score group in parallel to low genetic risk score group
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects 12 - 40 years 2. No history of alcohol abuse (\> 7 drinks per week) 3. History of fructose intake of \< 14 drinks per week 4. Caucasian ethnicity 5. BMI \> 25kg/m² - 32kg/m² or 85th -99th percentile but otherwise healthy
Exclusion criteria
1. ages \< 12 and \> 40 years 2. Pregnant/lactating 3. known alcohol abuse or fructose intake \> 14 drinks per week 4. not of Caucasian ethnicity 5. glucose levels \> 100 mg/dL if fasting, \> 140mg/dL if within 2 hours post meal and \> 200 mg/dL if random sample 6. taking anti-hypertensive, anti-diabetic, uric acid and/or lipid-lowering medications 7. known diagnosis of diabetes, fructose intolerance, chronic kidney disease, NAFLD or any liver-related disease, hypertriglyceridemia, polycystic ovary syndrome, hypothyroidism, obstructive sleep apnea, hypopituitarism and hypogonadism 8. BMI \< 25kg/m² or \> 32 kg/m² or \< 85th or \> 99th percentile 9. Liver fat fraction \>5% as per baseline MRI scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Liver Fat Content Based on Elastography | between week 0 (Baseline) and week 3 | Elastography (Fibroscan) will be used to measure changes in liver fat. |
| Mean Percent Change in Liver Fat Content Based on MRI | between week 0 (Baseline) and week 3 | Magnetic resonance imaging (MRI) will be used to measure changes in liver fat (% change in fat fraction). |
| Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG) | between week 0 (Baseline) and week 3 | VLDL-TG measurement in serum (mg/dl) at week 0 and Week 3. |
| Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Serum Concentrations of LDL Cholesterol | between week 0 (Baseline) and week 3 | Fasting concentrations of serum LDL cholesterol (mg/dl) will be measured.at week 0 and week 3 |
| Mean Change in AUC of Serum LDL Cholesterol | 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. |
| Mean Change in Serum Concentrations of Total Cholesterol | between week 0 (Baseline) and week 3 | Fasting serum concentrations of total cholesterol (mg/dl) will be measured at week 0 and week 3 |
| Mean Change in AUC of Serum Total Cholesterol | 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. |
| Mean Changes in Serum Concentrations of Uric Acid | between week 0 (Baseline) and week 3 | Fasting concentrations of serum uric acid (ng/ml) will be measured at week 0 and week 3 |
| Mean Changes in AUC of Serum Uric Acid | between week 0 (Baseline) and week 3 | Area under curve (AUC) (ng\*hr/ml) of serum uric acid for baseline and 3hr time points at week 0 and Week 3. |
| Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT). | between week 0 (Baseline) and week 3 | Fasting concentrations of serum ALT (nmol) will be measured at week 0 and week 3 |
| Mean Change in Serum Concentrations of Triglycerides | between week 0 (Baseline) and week 3 | Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3 |
| Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST). | between week 0 (Baseline) and week 3 | Serum concentrations of serum AST will be measured at week 0 and week 3 |
| Mean Change in AUC of Serum Aspartate Transaminase (AST). | between week 0 (Baseline) and week 3 | Area under curve (AUC) (IU\*hr/L) of serum AST for baseline and 3hr time points at week 0 and Week 3. |
| Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP) | between week 0 (Baseline) and week 3 | Fasting concentrations of serum ALP (nmol) will be measured at week 0 and week3 |
| Mean Change in AUC of Serum Alkaline Phosphatase (ALP) | between week 0 (Baseline) and week 3 | Area under curve (AUC) (nmol/hr) of serum ALP for baseline and 3hr time points at week 0 and Week 3. |
| Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT) | between week 0 (Baseline) and week 3 | Serum concentrations of GGT will be measured at week 0 and week 3 |
| Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT) | between week 0 (Baseline) and week 3 | Area under curve (AUC) (IU\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3. |
| Mean Change in AUC of Serum Alanine Transaminase (ALT) | between week 0 (Baseline) and week 3 | Area under curve (AUC) (nmol/hr) of serum ALT for baseline and 3hr time points at week 0 and Week 3. |
| Mean Change in AUC of Serum Triglycerides | 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. |
| Mean Change in Serum Concentrations of HDL Cholesterol | between week 0 (Baseline) and week 3 | Fasting concentrations of serum HDL cholesterol (mg/dl) will be measured at week 0 and week 3. |
| Mean Change in AUC of Serum HDL Cholesterol | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High 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 | 8 |
| Low 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 | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | High GRS Group | Low GRS Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Continuous | 26.88 years STANDARD_DEVIATION 9.6 | 24 years STANDARD_DEVIATION 9.2 | 25.53 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG)
Area under curve (AUC) (mg\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG) | 0.66 mg*hr/dl | Standard Deviation 0.35 |
| Low GRS Group | Mean Change in AUC of Serum Very Low Density Lipoprotein-triglycerides (VLDL-TG) | 0.75 mg*hr/dl | Standard Deviation 0.31 |
Comparison: This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.p-value: 0.5995% CI: [-0.27, 0.46]t-test, 2 sided
Primary
Mean Change in Liver Fat Content Based on Elastography
Elastography (Fibroscan) will be used to measure changes in liver fat.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Liver Fat Content Based on Elastography | -0.15 kilopascal (kPa) | Standard Deviation 0.85 |
| Low GRS Group | Mean Change in Liver Fat Content Based on Elastography | 1.10 kilopascal (kPa) | Standard Deviation 3.2 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.p-value: 0.495% CI: [-1.77, 0.76]Paired t-test
Primary
Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG)
VLDL-TG measurement in serum (mg/dl) at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG) | -0.021 mg/dl | Standard Deviation 0.05 |
| Low GRS Group | Mean Change in Serum Concentrations of Very Low Density Lipoprotein-triglycerides (VLDL-TG) | -0.007 mg/dl | Standard Deviation 0.03 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.p-value: 0.000695% CI: [-31.33, -10.72]Paired t-test
Primary
Mean Percent Change in Liver Fat Content Based on MRI
Magnetic resonance imaging (MRI) will be used to measure changes in liver fat (% change in fat fraction).
Time frame: between week 0 (Baseline) and week 3
Population: Due to COVID-19 limitations, only 4 participants had both the Week 0 (Baseline) and Week 3 MRIs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Percent Change in Liver Fat Content Based on MRI | -0.54 Percent fat fraction | Standard Deviation 0 |
| Low GRS Group | Mean Percent Change in Liver Fat Content Based on MRI | -0.33 Percent fat fraction | Standard Deviation 2.3 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.p-value: 0.7195% CI: [-3.33, 2.57]Paired t-test
Secondary
Mean Change in AUC of Serum Alanine Transaminase (ALT)
Area under curve (AUC) (nmol/hr) of serum ALT for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Alanine Transaminase (ALT) | 0.66 nmol/hr | Standard Deviation 0.3 |
| Low GRS Group | Mean Change in AUC of Serum Alanine Transaminase (ALT) | 0.54 nmol/hr | Standard Deviation 0.42 |
p-value: 0.5395% CI: [-0.52, 0.28]t-test, 2 sided
Secondary
Mean Change in AUC of Serum Alkaline Phosphatase (ALP)
Area under curve (AUC) (nmol/hr) of serum ALP for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Alkaline Phosphatase (ALP) | 0.63 nmol/hr | Standard Deviation 0.29 |
| Low GRS Group | Mean Change in AUC of Serum Alkaline Phosphatase (ALP) | 0.68 nmol/hr | Standard Deviation 0.16 |
p-value: 0.6795% CI: [-0.214, 0.321]t-test, 2 sided
Secondary
Mean Change in AUC of Serum Aspartate Transaminase (AST).
Area under curve (AUC) (IU\*hr/L) of serum AST for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Aspartate Transaminase (AST). | 0.61 IU*hr/L | Standard Deviation 0.28 |
| Low GRS Group | Mean Change in AUC of Serum Aspartate Transaminase (AST). | 0.73 IU*hr/L | Standard Deviation 0.17 |
p-value: 0.295% CI: [-0.59, 0.13]t-test, 2 sided
Secondary
Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT)
Area under curve (AUC) (IU\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT) | 0.61 IU*hr/L | Standard Deviation 0.31 |
| Low GRS Group | Mean Change in AUC of Serum Gamma Glutamyl Transpeptidase (GGT) | 0.50 IU*hr/L | Standard Deviation 0.28 |
p-value: 0.4995% CI: [-0.44, 0.22]t-test, 2 sided
Secondary
Mean Change in AUC of Serum HDL Cholesterol
Area under curve (AUC) (mg\*hr/dl) of serum HDL cholesterol for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum HDL Cholesterol | 0.59 mg*hr/dl | Standard Deviation 0.3 |
| Low GRS Group | Mean Change in AUC of Serum HDL Cholesterol | 0.66 mg*hr/dl | Standard Deviation 0.3 |
p-value: 0.6795% CI: [-0.27, 0.4]t-test, 2 sided
Secondary
Mean Change in AUC of Serum LDL Cholesterol
Area under curve (AUC) (mg\*hr/dl) of serum LDL cholesterol for baseline and 3hr time points at week 0 and Week 3.
Time frame: Week 0 (baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum LDL Cholesterol | 0.63 mg*hr/dl | Standard Deviation 0.27 |
| Low GRS Group | Mean Change in AUC of Serum LDL Cholesterol | 0.68 mg*hr/dl | Standard Deviation 0.25 |
p-value: 0.6995% CI: [-0.24, 0.34]t-test, 2 sided
Secondary
Mean Change in AUC of Serum Total Cholesterol
Area under curve (AUC) (mg\*hr/dl) of serum total cholesterol for baseline and 3hr time points at week 0 and Week 3.
Time frame: week 0 and week 3
Population: Adolescent and young adults of Caucasian descent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Total Cholesterol | 0.63 mg*hr/dl | Standard Deviation 0.27 |
| Low GRS Group | Mean Change in AUC of Serum Total Cholesterol | 0.66 mg*hr/dl | Standard Deviation 0.27 |
p-value: 0.895% CI: [-0.26, 0.33]t-test, 2 sided
Secondary
Mean Change in AUC of Serum Triglycerides
Area under curve (AUC) (mg\*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in AUC of Serum Triglycerides | 0.59 mg*hr/dl | Standard Deviation 0.27 |
| Low GRS Group | Mean Change in AUC of Serum Triglycerides | 0.57 mg*hr/dl | Standard Deviation 0.35 |
Comparison: This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.p-value: 0.8995% CI: [-0.37, 0.33]t-test, 2 sided
Secondary
Mean Change in Serum Concentrations of HDL Cholesterol
Fasting concentrations of serum HDL cholesterol (mg/dl) will be measured at week 0 and week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of HDL Cholesterol | -2.70 mg/dl | Standard Deviation 15.9 |
| Low GRS Group | Mean Change in Serum Concentrations of HDL Cholesterol | 0.39 mg/dl | Standard Deviation 20.7 |
Comparison: The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.p-value: 0.3695% CI: [-14.28, 5.55]Paired t-test
Secondary
Mean Change in Serum Concentrations of LDL Cholesterol
Fasting concentrations of serum LDL cholesterol (mg/dl) will be measured.at week 0 and week 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of LDL Cholesterol | -4.40 mg/dl | Standard Deviation 36.2 |
| Low GRS Group | Mean Change in Serum Concentrations of LDL Cholesterol | 0.96 mg/dl | Standard Deviation 13.6 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.p-value: 0.0995% CI: [-45.76, 3.69]Paired t-test
Secondary
Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT).
Fasting concentrations of serum ALT (nmol) will be measured at week 0 and week 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT). | -0.02 nmol | Standard Deviation 0.05 |
| Low GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Alanine Transaminase- ALT). | -0.007 nmol | Standard Deviation 0.03 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.p-value: 0.0495% CI: [-0.03, -0.0009]Paired t-test
Secondary
Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP)
Fasting concentrations of serum ALP (nmol) will be measured at week 0 and week3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP) | 20.38 nmol | Standard Deviation 71.14 |
| Low GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Alkaline Phosphatase-ALP) | -5.24 nmol | Standard Deviation 21.27 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.p-value: 0.2195% CI: [-17.76, 75.67]Paired t-test
Secondary
Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST).
Serum concentrations of serum AST will be measured at week 0 and week 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST). | -1.91 IU/L | Standard Deviation 14.9 |
| Low GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Aspartate Transaminase-AST). | 1.28 IU/L | Standard Deviation 2.8 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.p-value: 0.2595% CI: [-16.9, 58.08]Paired t-test
Secondary
Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT)
Serum concentrations of GGT will be measured at week 0 and week 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT) | 0.26 IU/L | Standard Deviation 0.61 |
| Low GRS Group | Mean Change in Serum Concentrations of Liver Function Marker (Gamma Glutamyl Transpeptidase-GGT) | 0.01 IU/L | Standard Deviation 0.04 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.p-value: 0.4195% CI: [-0.12, 0.28]Paired t-test
Secondary
Mean Change in Serum Concentrations of Total Cholesterol
Fasting serum concentrations of total cholesterol (mg/dl) will be measured at week 0 and week 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Total Cholesterol | -2.77 mg/dl | Standard Deviation 53.2 |
| Low GRS Group | Mean Change in Serum Concentrations of Total Cholesterol | 0.92 mg/dl | Standard Deviation 25.21 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.p-value: 0.0795% CI: [-62.39, 3.17]Paired t-test
Secondary
Mean Change in Serum Concentrations of Triglycerides
Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Change in Serum Concentrations of Triglycerides | 21.75 mg/dl | Standard Deviation 60.6 |
| Low GRS Group | Mean Change in Serum Concentrations of Triglycerides | -2.14 mg/dl | Standard Deviation 29.9 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.p-value: 0.01795% CI: [-37.75, -4.38]Paired t-test
Secondary
Mean Changes in AUC of Serum Uric Acid
Area under curve (AUC) (ng\*hr/ml) of serum uric acid for baseline and 3hr time points at week 0 and Week 3.
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Changes in AUC of Serum Uric Acid | 0.73 ng*hr/ml | Standard Deviation 0.27 |
| Low GRS Group | Mean Changes in AUC of Serum Uric Acid | 0.52 ng*hr/ml | Standard Deviation 0.38 |
p-value: 0.2295% CI: [-0.58, 0.15]t-test, 2 sided
Secondary
Mean Changes in Serum Concentrations of Uric Acid
Fasting concentrations of serum uric acid (ng/ml) will be measured at week 0 and week 3
Time frame: between week 0 (Baseline) and week 3
Population: Adolescents and young adults of Caucasian descent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High GRS Group | Mean Changes in Serum Concentrations of Uric Acid | 0.21 ng/ml | Standard Deviation 1.14 |
| Low GRS Group | Mean Changes in Serum Concentrations of Uric Acid | -0.36 ng/ml | Standard Deviation 0.89 |
Comparison: The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.p-value: 0.1795% CI: [-0.18, 0.91]Paired t-test