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

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

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.

Study Overview

• Status: Completed
• Conditions: Biomarkers
• Intervention / Treatment: Other: Sugar sweetened beverage (SSB)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 33000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard T.H. Chan School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The Nurses' Health Study (NHS) is a prospective cohort study of 121,700 female registered nurses aged 30-55 years at baseline in 1976. Mailed questionnaires were administered biennially to collect data on medical, dietary, and lifestyle factors, with a follow-up rate exceeding 90% for each 2-year cycle. Blood samples were collected from 32,826 participants between 1989 and 1990 (biospecimen collection cycle 1) and 18,717 participants between 2000 and 2001 (biospecimen collection cycle 2). Participants who provided a blood specimen were generally similar to those who did not in terms of diet and lifestyle

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

NHS; Least-squares mean (95% CI) concentrations of biomarkers by frequency of sugar sweetened beverage (SSB) intake among participants free of diabetes and cardiovascular disease in the NHS. Least-squares mean (95% CI) concentrations of biomarkers by frequency of artificially sweetened beverage (ASB) intake among participants free of diabetes and cardiovascular disease in the NHS. Least-squares mean (95% CI) concentrations of biomarkers by frequency of fruit juice intake among participants free of diabetes and cardiovascular disease in the NHS.

Other: Sugar sweetened beverage (SSB); This is an observational study examining sugar sweetened beverage intake in relation to biomarkers in the NHS.; Other Names: Artificially sweetened beverage (ASB), juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetuin-A	Biomarkers of liver function	Blood collection cycle 1 (1989-1990)
Fetuin-A	Biomarkers of liver function	Blood collection cyle 2 (2000-2001)
Alanine transaminase	Biomarkers of liver function	Blood collection cycle 1 (1989-1990)
Alanine transaminase	Biomarkers of liver function	Blood collection cyle 2 (2000-2001)
Gamma-glutamyl transferase	Biomarkers of liver function	Blood collection cycle 1 (1989-1990)
Gamma-glutamyl transferase	Biomarkers of liver function	Blood collection cyle 2 (2000-2001)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Triglycerides	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
High-density lipoprotein cholesterol (HDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
High-density lipoprotein cholesterol (HDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Low-density lipoprotein cholesterol (LDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Low-density lipoprotein cholesterol (LDL-C)	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Total cholesterol	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Total cholesterol	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
Total cholesterol/HDL-C ratio	Biomarkers of lipid metabolism	Blood collection cycle 1 (1989-1990)
Total cholesterol/HDL-C ratio	Biomarkers of lipid metabolism	Blood collection cycle 2 (2000-2001)
C-reactive protein (CRP)	Biomarkers of inflammation	Blood collection cycle 1 (1989-1990)
C-reactive protein (CRP)	Biomarkers of inflammation	Blood collection cycle 2 (2000-2001)
Intracellular adhesion molecule 1 (ICAM-1)	Biomarkers of inflammation	Blood collection cycle 1 (1989-1990)
Intracellular adhesion molecule 1 (ICAM-1)	Biomarkers of inflammation	Blood collection cycle 2 (2000-2001)
Vascular cell adhesion protein 1 (VCAM-1)	Biomarkers of inflammation	Blood collection cycle 1 (1989-1990)
Vascular cell adhesion protein 1 (VCAM-1)	Biomarkers of inflammation	Blood collection cycle 2 (2000-2001)
Insulin	Biomarkers of glucose metabolism	Blood collection cycle 1 (1989-1990)
Insulin	Biomarkers of glucose metabolism	Blood collection cycle 2 (2000-2001)
Hemoglobin A1c	Biomarkers of glucose metabolism	Blood collection cycle 1 (1989-1990)
Hemoglobin A1c	Biomarkers of glucose metabolism	Blood collection cycle 2 (2000-2001)

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Vasanti Malik, ScD, Research Scientist

Publications and helpful links

General Publications

• 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. doi: 10.1093/ajcn/75.3.492.
• 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.
• 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.
• 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.
• 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.
• 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. doi: 10.1001/jama.292.8.927.
• 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. doi: 10.1093/oxfordjournals.aje.a114086.
• 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.
• Malik VS, Popkin BM, Bray GA, Despres 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.
• 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.
• 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.
• 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.
• 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. doi: 10.1093/ije/18.4.858.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 1999
• Primary Completion (Actual): March 31, 2009
• Study Completion (Actual): March 31, 2009

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Sugar sweetened beverage, biomarker
• Other Study ID Numbers: 1999-P-011114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data are de-identified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No