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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK056336-16S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High GRS group | Experimental | 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. |
|
| Low GRS group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar drink | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Liver Fat Content Based on Elastography | Elastography (Fibroscan) will be used to measure changes in liver fat. | between week 0 (Baseline) and week 3 |
| 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). | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Serum Concentrations of Triglycerides | Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3 | between week 0 (Baseline) and week 3 |
| Mean Change in AUC of Serum Triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saroja Voruganti | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Nutrition Research Institute | Kannapolis | North Carolina | 28081 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27543837 | Background | Younossi ZM, Blissett D, Blissett R, Henry L, Stepanova M, Younossi Y, Racila A, Hunt S, Beckerman R. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology. 2016 Nov;64(5):1577-1586. doi: 10.1002/hep.28785. Epub 2016 Sep 26. | |
| 18769702 | Background | Vos MB, Kimmons JE, Gillespie C, Welsh J, Blanck HM. Dietary fructose consumption among US children and adults: the Third National Health and Nutrition Examination Survey. Medscape J Med. 2008 Jul 9;10(7):160. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
9- 36 months following article publication
Investigators whose proposed use of the data has been approved by the institutional review board, independent ethics committee or research ethics committee, as applicable and an executed data use agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Same as participant flow.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Liver Fat Content Based on Elastography | Elastography (Fibroscan) will be used to measure changes in liver fat. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | kilopascal (kPa) | between week 0 (Baseline) and week 3 |
|
From the time of signing informed consent through completion of study, a total of 3 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saroja Voruganti, PhD | University of North Carolina at Chapel Hill | 704-250-5009 | saroja@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2021 | May 22, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2021 | Jun 16, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000080845 | Sugar-Sweetened Beverages |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Participants are assigned to high genetic risk score group in parallel to low genetic risk score group
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Area under curve (AUC) (mg*hr/dl) of serum VLDL-TG for baseline and 3hr time points at week 0 and Week 3.
| between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (baseline) and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | Week 0 (baseline) and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | week 0 and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 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 | between week 0 (Baseline) and week 3 |
| 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. | between week 0 (Baseline) and week 3 |
| 25514388 | Background | Moore JB, Gunn PJ, Fielding BA. The role of dietary sugars and de novo lipogenesis in non-alcoholic fatty liver disease. Nutrients. 2014 Dec 10;6(12):5679-703. doi: 10.3390/nu6125679. |
| 15983189 | Background | Faeh D, Minehira K, Schwarz JM, Periasamy R, Park S, Tappy L. Effect of fructose overfeeding and fish oil administration on hepatic de novo lipogenesis and insulin sensitivity in healthy men. Diabetes. 2005 Jul;54(7):1907-13. doi: 10.2337/diabetes.54.7.1907. |
| 27995280 | Background | Alwahsh SM, Gebhardt R. Dietary fructose as a risk factor for non-alcoholic fatty liver disease (NAFLD). Arch Toxicol. 2017 Apr;91(4):1545-1563. doi: 10.1007/s00204-016-1892-7. Epub 2016 Dec 19. |
| 19381015 | Background | Stanhope KL, Schwarz JM, Keim NL, Griffen SC, Bremer AA, Graham JL, Hatcher B, Cox CL, Dyachenko A, Zhang W, McGahan JP, Seibert A, Krauss RM, Chiu S, Schaefer EJ, Ai M, Otokozawa S, Nakajima K, Nakano T, Beysen C, Hellerstein MK, Berglund L, Havel PJ. Consuming fructose-sweetened, not glucose-sweetened, beverages increases visceral adiposity and lipids and decreases insulin sensitivity in overweight/obese humans. J Clin Invest. 2009 May;119(5):1322-34. doi: 10.1172/JCI37385. Epub 2009 Apr 20. |
| 25904601 | Background | Stanhope KL, Medici V, Bremer AA, Lee V, Lam HD, Nunez MV, Chen GX, Keim NL, Havel PJ. A dose-response study of consuming high-fructose corn syrup-sweetened beverages on lipid/lipoprotein risk factors for cardiovascular disease in young adults. Am J Clin Nutr. 2015 Jun;101(6):1144-54. doi: 10.3945/ajcn.114.100461. Epub 2015 Apr 22. |
| 28972537 | Background | Softic S, Gupta MK, Wang GX, Fujisaka S, O'Neill BT, Rao TN, Willoughby J, Harbison C, Fitzgerald K, Ilkayeva O, Newgard CB, Cohen DE, Kahn CR. Divergent effects of glucose and fructose on hepatic lipogenesis and insulin signaling. J Clin Invest. 2017 Nov 1;127(11):4059-4074. doi: 10.1172/JCI94585. Epub 2017 Oct 3. |
| 26005677 | Background | Basaranoglu M, Basaranoglu G, Bugianesi E. Carbohydrate intake and nonalcoholic fatty liver disease: fructose as a weapon of mass destruction. Hepatobiliary Surg Nutr. 2015 Apr;4(2):109-16. doi: 10.3978/j.issn.2304-3881.2014.11.05. |
| 24065788 | Background | Johnson RJ, Nakagawa T, Sanchez-Lozada LG, Shafiu M, Sundaram S, Le M, Ishimoto T, Sautin YY, Lanaspa MA. Sugar, uric acid, and the etiology of diabetes and obesity. Diabetes. 2013 Oct;62(10):3307-15. doi: 10.2337/db12-1814. |
| 26738417 | Background | Zhou Y, Wei F, Fan Y. High serum uric acid and risk of nonalcoholic fatty liver disease: A systematic review and meta-analysis. Clin Biochem. 2016 May;49(7-8):636-42. doi: 10.1016/j.clinbiochem.2015.12.010. Epub 2015 Dec 29. |
| 22617559 | Background | Goran MI, Walker R, Allayee H. Genetic-related and carbohydrate-related factors affecting liver fat accumulation. Curr Opin Clin Nutr Metab Care. 2012 Jul;15(4):392-6. doi: 10.1097/MCO.0b013e3283544477. |
| 21423719 | Background | Speliotes EK, Yerges-Armstrong LM, Wu J, Hernaez R, Kim LJ, Palmer CD, Gudnason V, Eiriksdottir G, Garcia ME, Launer LJ, Nalls MA, Clark JM, Mitchell BD, Shuldiner AR, Butler JL, Tomas M, Hoffmann U, Hwang SJ, Massaro JM, O'Donnell CJ, Sahani DV, Salomaa V, Schadt EE, Schwartz SM, Siscovick DS; NASH CRN; GIANT Consortium; MAGIC Investigators; Voight BF, Carr JJ, Feitosa MF, Harris TB, Fox CS, Smith AV, Kao WH, Hirschhorn JN, Borecki IB; GOLD Consortium. Genome-wide association analysis identifies variants associated with nonalcoholic fatty liver disease that have distinct effects on metabolic traits. PLoS Genet. 2011 Mar;7(3):e1001324. doi: 10.1371/journal.pgen.1001324. Epub 2011 Mar 10. |
| 20962157 | Background | Davis JN, Le KA, Walker RW, Vikman S, Spruijt-Metz D, Weigensberg MJ, Allayee H, Goran MI. Increased hepatic fat in overweight Hispanic youth influenced by interaction between genetic variation in PNPLA3 and high dietary carbohydrate and sugar consumption. Am J Clin Nutr. 2010 Dec;92(6):1522-7. doi: 10.3945/ajcn.2010.30185. Epub 2010 Oct 20. |
| 26043229 | Background | Santoro N, Caprio S, Pierpont B, Van Name M, Savoye M, Parks EJ. Hepatic De Novo Lipogenesis in Obese Youth Is Modulated by a Common Variant in the GCKR Gene. J Clin Endocrinol Metab. 2015 Aug;100(8):E1125-32. doi: 10.1210/jc.2015-1587. Epub 2015 Jun 4. |
| 27935520 | Background | Ter Horst KW, Schene MR, Holman R, Romijn JA, Serlie MJ. Effect of fructose consumption on insulin sensitivity in nondiabetic subjects: a systematic review and meta-analysis of diet-intervention trials. Am J Clin Nutr. 2016 Dec;104(6):1562-1576. doi: 10.3945/ajcn.116.137786. Epub 2016 Nov 9. |
| 28579536 | Background | Schwarz JM, Noworolski SM, Erkin-Cakmak A, Korn NJ, Wen MJ, Tai VW, Jones GM, Palii SP, Velasco-Alin M, Pan K, Patterson BW, Gugliucci A, Lustig RH, Mulligan K. Effects of Dietary Fructose Restriction on Liver Fat, De Novo Lipogenesis, and Insulin Kinetics in Children With Obesity. Gastroenterology. 2017 Sep;153(3):743-752. doi: 10.1053/j.gastro.2017.05.043. Epub 2017 Jun 1. |
| 21849529 | Background | Stanhope KL, Bremer AA, Medici V, Nakajima K, Ito Y, Nakano T, Chen G, Fong TH, Lee V, Menorca RI, Keim NL, Havel PJ. Consumption of fructose and high fructose corn syrup increase postprandial triglycerides, LDL-cholesterol, and apolipoprotein-B in young men and women. J Clin Endocrinol Metab. 2011 Oct;96(10):E1596-605. doi: 10.1210/jc.2011-1251. Epub 2011 Aug 17. |
| 25825943 | Background | Schwarz JM, Noworolski SM, Wen MJ, Dyachenko A, Prior JL, Weinberg ME, Herraiz LA, Tai VW, Bergeron N, Bersot TP, Rao MN, Schambelan M, Mulligan K. Effect of a High-Fructose Weight-Maintaining Diet on Lipogenesis and Liver Fat. J Clin Endocrinol Metab. 2015 Jun;100(6):2434-42. doi: 10.1210/jc.2014-3678. Epub 2015 Mar 31. |
| 20948525 | Background | Ventura EE, Davis JN, Goran MI. Sugar content of popular sweetened beverages based on objective laboratory analysis: focus on fructose content. Obesity (Silver Spring). 2011 Apr;19(4):868-74. doi: 10.1038/oby.2010.255. Epub 2010 Oct 14. |
| 17991646 | Background | Akhavan T, Anderson GH. Effects of glucose-to-fructose ratios in solutions on subjective satiety, food intake, and satiety hormones in young men. Am J Clin Nutr. 2007 Nov;86(5):1354-63. doi: 10.1093/ajcn/86.5.1354. |
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| 21252253 | Background | Hudgins LC, Parker TS, Levine DM, Hellerstein MK. A dual sugar challenge test for lipogenic sensitivity to dietary fructose. J Clin Endocrinol Metab. 2011 Mar;96(3):861-8. doi: 10.1210/jc.2010-2007. Epub 2011 Jan 20. |
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| 25659155 | Background | Shin HJ, Kim HG, Kim MJ, Koh H, Kim HY, Roh YH, Lee MJ. Normal range of hepatic fat fraction on dual- and triple-echo fat quantification MR in children. PLoS One. 2015 Feb 6;10(2):e0117480. doi: 10.1371/journal.pone.0117480. eCollection 2015. |
| 24452634 | Background | Bonder A, Afdhal N. Utilization of FibroScan in clinical practice. Curr Gastroenterol Rep. 2014 Feb;16(2):372. doi: 10.1007/s11894-014-0372-6. |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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 |
|
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| 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). | Due to COVID-19 limitations, only 4 participants had both the Week 0 (Baseline) and Week 3 MRIs. | Posted | Mean | Standard Deviation | Percent fat fraction | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg/dl | between week 0 (Baseline) and week 3 |
|
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg*hr/dl | between week 0 (Baseline) and week 3 |
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| Secondary | Mean Change in Serum Concentrations of Triglycerides | Fasting concentrations of serum triglycerides (mg/dl) will be measured at week 0 and 3 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg/dl | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg*hr/dl | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg/dl | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg*hr/dl | between week 0 (baseline) and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg/dl | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg*hr/dl | Week 0 (baseline) and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | mg/dl | between week 0 (Baseline) and week 3 |
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| 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. | Adolescent and young adults of Caucasian descent. | Posted | Mean | Standard Deviation | mg*hr/dl | week 0 and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | ng/ml | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | ng*hr/ml | between week 0 (Baseline) and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | nmol | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | nmol/hr | between week 0 (Baseline) and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | IU/L | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | IU*hr/L | between week 0 (Baseline) and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | nmol | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | nmol/hr | between week 0 (Baseline) and week 3 |
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| 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 | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | IU/L | between week 0 (Baseline) and week 3 |
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| 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. | Adolescents and young adults of Caucasian descent | Posted | Mean | Standard Deviation | IU*hr/L | between week 0 (Baseline) and week 3 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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 | 0 | 7 | 0 | 7 | 0 | 7 |
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