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

Completed

• Conditions: Biomarkers
• Interventions: Other: Sugar sweetened beverage (SSB)

• Registration Number: NCT03173586
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

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 Timeline

• Study Start: 1999-09-16
• Primary Completion: 2009-03-31
• Study Completion: 2009-03-31
• Status Verified: 2017-05
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Study First Posted: 2017-06-02
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NHS	Sugar sweetened beverage (SSB)	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.

Primary Outcome Measures

Name	Time	Method
Gamma-glutamyl transferase	Blood collection cyle 2 (2000-2001)	Biomarkers of liver function
Fetuin-A	Blood collection cyle 2 (2000-2001)	Biomarkers of liver function
Alanine transaminase	Blood collection cyle 2 (2000-2001)	Biomarkers of liver function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Harvard T.H. Chan School of Public Health; 🇺🇸 Boston, Massachusetts, United States