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

NCT03173586 | Completed

• 1 other identifier: 1999-P-011114
• Study Type: observational
• Target: 33,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biomarkers

Keywords

Sugar sweetened beverage, biomarker

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (20)

• Triglycerides

  Blood collection cycle 1 (1989-1990)

• Triglycerides

  Blood collection cycle 2 (2000-2001)

• High-density lipoprotein cholesterol (HDL-C)

  Blood collection cycle 1 (1989-1990)

• High-density lipoprotein cholesterol (HDL-C)

  Blood collection cycle 2 (2000-2001)

• Low-density lipoprotein cholesterol (LDL-C)

  Blood collection cycle 1 (1989-1990)

Study Arms (1)

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)

Interventions

Sugar sweetened beverage (SSB) OTHER

This is an observational study examining sugar sweetened beverage intake in relation to biomarkers in the NHS.

Also known as: Artificially sweetened beverage (ASB), juice

NHS

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: Our analysis was based on a cohort of female registered nurses.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead

Study Sites (1)

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (20)

• 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.

  PMID: 20693348 BACKGROUND

• 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.

  PMID: 25735740 BACKGROUND

• 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.

  PMID: 22412070 BACKGROUND

• 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.

  PMID: 18390796 BACKGROUND

• 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.

  PMID: 15328324 BACKGROUND

• 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.

  PMID: 19151203 BACKGROUND

• 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.

  PMID: 21430119 BACKGROUND

• 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.

  PMID: 4014201 BACKGROUND

• 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.

  PMID: 2621022 BACKGROUND

• 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.

  PMID: 24105100 BACKGROUND

• 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.

  PMID: 21543531 BACKGROUND

• 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.

  PMID: 22923470 BACKGROUND

• 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.

  PMID: 23966427 BACKGROUND

• 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.

  PMID: 11864854 BACKGROUND

• 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.

  PMID: 19211821 BACKGROUND

• 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.

  PMID: 22552035 BACKGROUND

• 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.

  PMID: 23318721 BACKGROUND

• 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.

  PMID: 26048094 BACKGROUND

• 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.

  PMID: 26764316 BACKGROUND

• 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.

  PMID: 27465378 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The major goal of the project was to analyze blood samples collected from 33,000 women participating in the Nurses' Health Study. The aim of the original grant was to asses plasma sex hormone levels in relation to risk of breast cancer; plasma beta-carotene, Vitamin E and omega-3 fatty acids and risk of breast and colon cancer; specific lipoprotein fractions, apoproteins and fatty acids and risk of CVD.

MeSH Terms

Interventions

Sugar-Sweetened Beverages; Artificially Sweetened Beverages; 5-Aminolevulinate Synthetase

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Vasanti Malik, ScD

  Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 2, 2017
• Study Start: September 16, 1999
• Primary Completion: March 31, 2009
• Study Completion: March 31, 2009
• Last Updated: June 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)