Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women

Biomarkers Clinical Trial

Official title:

Association Between Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173586
• Other study ID #: 1999-P-011114
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: May 30, 2017
• Start date: September 16, 1999
• Est. completion date: March 31, 2009

Study information

• Verified date: May 2017
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a secondary analysis of data collected in the Nurses' Health Study (NHS) that will evaluat the association between intake of sugar sweetened beverages (SSB), juice and artificially sweetened beverages in relation to biomarkers of hepatic function, lipid metabolism, inflammation and glycemic control.

Description:

The investigators will analyze cross-sectional data from 8,492 participants in the Nurses' Health Study who were free of diabetes and cardiovascular disease to evaluate the association between intake of sugar sweetened beverages (SSB), juice and artificially sweetened beverages (ASB) and biomarkers of hepatic function, lipid metabolism, inflammation and glycemic control. Biomarkers were measured from blood samples that were collected in 2 cycles, approximately 10 years apart.

Specifically, multivariate linear regression will be used to assess the associations of SSB, ASB, and fruit juice intake with concentrations of fetuin-A, alanine transaminase, gamma-glutamyl transferase, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol, C-reactive protein (CRP), intracellular adhesion molecule 1 (ICAM-1), vascular cell adhesion protein 1 (VCAM-1), adiponectin, insulin, and hemoglobin A1c as well as total cholesterol/HDL-C ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33000
• Est. completion date: March 31, 2009
• Est. primary completion date: March 31, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

For the current study, we included participants who provided a blood sample and were previously selected as controls for nested case-control analyses of type 2 diabetes, coronary heart disease, stroke, colon cancer, colon polyps, pancreatic cancer, and breast cancer in the Nurse's Health Study.

Exclusion Criteria:

Participants with self-reported prevalent diabetes or cardiovascular disease (CVD) at blood draw were excluded. After exclusions, a total of 8,492 individuals (6,961 from cycle 1 and 1,531 from cycle 2) with valid beverage intake data were included in the current analysis.

Related Conditions & MeSH terms

• Biomarkers

Intervention

Other:
• Sugar sweetened beverage (SSB)
This is an observational study examining sugar sweetened beverage intake in relation to biomarkers in the NHS.

Locations

Country	Name	City	State
United States	Harvard T.H. Chan School of Public Health	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (20)

AlEssa HB, Ley SH, Rosner B, Malik VS, Willett WC, Campos H, Hu FB. High Fiber and Low Starch Intakes Are Associated with Circulating Intermediate Biomarkers of Type 2 Diabetes among Women. J Nutr. 2016 Feb;146(2):306-17. doi: 10.3945/jn.115.219915. Epub 2016 Jan 13. — View Citation

Bazzano LA, Li TY, Joshipura KJ, Hu FB. Intake of fruit, vegetables, and fruit juices and risk of diabetes in women. Diabetes Care. 2008 Jul;31(7):1311-7. doi: 10.2337/dc08-0080. Epub 2008 Apr 4. — View Citation

de Koning L, Malik VS, Kellogg MD, Rimm EB, Willett WC, Hu FB. Sweetened beverage consumption, incident coronary heart disease, and biomarkers of risk in men. Circulation. 2012 Apr 10;125(14):1735-41, S1. doi: 10.1161/CIRCULATIONAHA.111.067017. Epub 2012 Mar 12. — View Citation

de Koning L, Malik VS, Rimm EB, Willett WC, Hu FB. Sugar-sweetened and artificially sweetened beverage consumption and risk of type 2 diabetes in men. Am J Clin Nutr. 2011 Jun;93(6):1321-7. doi: 10.3945/ajcn.110.007922. Epub 2011 Mar 23. — View Citation

Fung TT, Malik V, Rexrode KM, Manson JE, Willett WC, Hu FB. Sweetened beverage consumption and risk of coronary heart disease in women. Am J Clin Nutr. 2009 Apr;89(4):1037-42. doi: 10.3945/ajcn.2008.27140. Epub 2009 Feb 11. — View Citation

Ley SH, Sun Q, Jimenez MC, Rexrode KM, Manson JE, Jensen MK, Rimm EB, Hu FB. Association between alcohol consumption and plasma fetuin-A and its contribution to incident type 2 diabetes in women. Diabetologia. 2014 Jan;57(1):93-101. doi: 10.1007/s00125-013-3077-8. Epub 2013 Oct 9. — View Citation

Liu S, Manson JE, Buring JE, Stampfer MJ, Willett WC, Ridker PM. Relation between a diet with a high glycemic load and plasma concentrations of high-sensitivity C-reactive protein in middle-aged women. Am J Clin Nutr. 2002 Mar;75(3):492-8. — View Citation

Malik VS, Chiuve SE, Campos H, Rimm EB, Mozaffarian D, Hu FB, Sun Q. Circulating Very-Long-Chain Saturated Fatty Acids and Incident Coronary Heart Disease in US Men and Women. Circulation. 2015 Jul 28;132(4):260-8. doi: 10.1161/CIRCULATIONAHA.114.014911. Epub 2015 Jun 5. — View Citation

Malik VS, Pan A, Willett WC, Hu FB. Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Oct;98(4):1084-102. doi: 10.3945/ajcn.113.058362. Epub 2013 Aug 21. Review. — View Citation

Malik VS, Popkin BM, Bray GA, Després JP, Willett WC, Hu FB. Sugar-sweetened beverages and risk of metabolic syndrome and type 2 diabetes: a meta-analysis. Diabetes Care. 2010 Nov;33(11):2477-83. doi: 10.2337/dc10-1079. Epub 2010 Aug 6. Review. — View Citation

Nettleton JA, Lutsey PL, Wang Y, Lima JA, Michos ED, Jacobs DR Jr. Diet soda intake and risk of incident metabolic syndrome and type 2 diabetes in the Multi-Ethnic Study of Atherosclerosis (MESA). Diabetes Care. 2009 Apr;32(4):688-94. doi: 10.2337/dc08-1799. Epub 2009 Jan 16. — View Citation

Nimptsch K, Brand-Miller JC, Franz M, Sampson L, Willett WC, Giovannucci E. Dietary insulin index and insulin load in relation to biomarkers of glycemic control, plasma lipids, and inflammation markers. Am J Clin Nutr. 2011 Jul;94(1):182-90. doi: 10.3945/ajcn.110.009555. Epub 2011 May 4. — View Citation

Pan A, Malik VS, Hao T, Willett WC, Mozaffarian D, Hu FB. Changes in water and beverage intake and long-term weight changes: results from three prospective cohort studies. Int J Obes (Lond). 2013 Oct;37(10):1378-85. doi: 10.1038/ijo.2012.225. Epub 2013 Jan 15. — View Citation

Pan A, Malik VS, Schulze MB, Manson JE, Willett WC, Hu FB. Plain-water intake and risk of type 2 diabetes in young and middle-aged women. Am J Clin Nutr. 2012 Jun;95(6):1454-60. doi: 10.3945/ajcn.111.032698. Epub 2012 May 2. — View Citation

Salvini S, Hunter DJ, Sampson L, Stampfer MJ, Colditz GA, Rosner B, Willett WC. Food-based validation of a dietary questionnaire: the effects of week-to-week variation in food consumption. Int J Epidemiol. 1989 Dec;18(4):858-67. — View Citation

Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA. 2004 Aug 25;292(8):927-34. — View Citation

Sun Q, Cornelis MC, Manson JE, Hu FB. Plasma levels of fetuin-A and hepatic enzymes and risk of type 2 diabetes in women in the U.S. Diabetes. 2013 Jan;62(1):49-55. doi: 10.2337/db12-0372. Epub 2012 Aug 24. — View Citation

Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65. — View Citation

Xi B, Huang Y, Reilly KH, Li S, Zheng R, Barrio-Lopez MT, Martinez-Gonzalez MA, Zhou D. Sugar-sweetened beverages and risk of hypertension and CVD: a dose-response meta-analysis. Br J Nutr. 2015 Mar 14;113(5):709-17. doi: 10.1017/S0007114514004383. Epub 2015 Mar 4. Review. — View Citation

Yu Z, Malik VS, Keum N, Hu FB, Giovannucci EL, Stampfer MJ, Willett WC, Fuchs CS, Bao Y. Associations between nut consumption and inflammatory biomarkers. Am J Clin Nutr. 2016 Sep;104(3):722-8. doi: 10.3945/ajcn.116.134205. Epub 2016 Jul 27. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetuin-A	Biomarkers of liver function	Blood collection cycle 1 (1989-1990)
Primary	Fetuin-A	Biomarkers of liver function	Blood collection cyle 2 (2000-2001)
Primary	Alanine transaminase	Biomarkers of liver function	Blood collection cycle 1 (1989-1990)
Primary	Alanine transaminase	Biomarkers of liver function	Blood collection cyle 2 (2000-2001)
Primary	Gamma-glutamyl transferase	Biomarkers of liver function	Blood collection cycle 1 (1989-1990)
Primary	Gamma-glutamyl transferase	Biomarkers of liver function	Blood collection cyle 2 (2000-2001)
Secondary	Triglycerides	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Secondary	Triglycerides	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Secondary	High-density lipoprotein cholesterol (HDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Secondary	High-density lipoprotein cholesterol (HDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Secondary	Low-density lipoprotein cholesterol (LDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Secondary	Low-density lipoprotein cholesterol (LDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Secondary	Total cholesterol	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Secondary	Total cholesterol	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Secondary	Total cholesterol/HDL-C ratio	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Secondary	Total cholesterol/HDL-C ratio	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Secondary	C-reactive protein (CRP)	Biomarkers of inflammation	Blood collection cycle 1 (1989-1990)
Secondary	C-reactive protein (CRP)	Biomarkers of inflammation	Blood collection cycle 2 (2000-2001)
Secondary	Intracellular adhesion molecule 1 (ICAM-1)	Biomarkers of inflammation	Blood collection cycle 1 (1989-1990)
Secondary	Intracellular adhesion molecule 1 (ICAM-1)	Biomarkers of inflammation	Blood collection cycle 2 (2000-2001)
Secondary	Vascular cell adhesion protein 1 (VCAM-1)	Biomarkers of inflammation	Blood collection cycle 1 (1989-1990)
Secondary	Vascular cell adhesion protein 1 (VCAM-1)	Biomarkers of inflammation	Blood collection cycle 2 (2000-2001)
Secondary	Insulin	Biomarkers of glucose metabolism	Blood collection cycle 1 (1989-1990)
Secondary	Insulin	Biomarkers of glucose metabolism	Blood collection cycle 2 (2000-2001)
Secondary	Hemoglobin A1c	Biomarkers of glucose metabolism	Blood collection cycle 1 (1989-1990)
Secondary	Hemoglobin A1c	Biomarkers of glucose metabolism	Blood collection cycle 2 (2000-2001)