Skip to main content
OpenTrials
Completed

NCT Number: NCT03173586

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

30 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Harvard T.H. Chan School of Public Health

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugar sweetened beverage (SSB)

Other

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

Other names: Artificially sweetened beverage (ASB), juice

Primary outcomes

  1. Fetuin-A

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of liver function

  2. Fetuin-A

    Time frame: Blood collection cyle 2 (2000-2001)

    Biomarkers of liver function

  3. Alanine transaminase

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of liver function

  4. Alanine transaminase

    Time frame: Blood collection cyle 2 (2000-2001)

    Biomarkers of liver function

  5. Gamma-glutamyl transferase

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of liver function

  6. Gamma-glutamyl transferase

    Time frame: Blood collection cyle 2 (2000-2001)

    Biomarkers of liver function

Secondary outcomes

  1. Triglycerides

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of lipid metabolism

  2. Triglycerides

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of lipid metabolism

  3. High-density lipoprotein cholesterol (HDL-C)

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of lipid metabolism

  4. High-density lipoprotein cholesterol (HDL-C)

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of lipid metabolism

  5. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of lipid metabolism

  6. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of lipid metabolism

  7. Total cholesterol

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of lipid metabolism

  8. Total cholesterol

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of lipid metabolism

  9. Total cholesterol/HDL-C ratio

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of lipid metabolism

  10. Total cholesterol/HDL-C ratio

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of lipid metabolism

  11. C-reactive protein (CRP)

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of inflammation

  12. C-reactive protein (CRP)

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of inflammation

  13. Intracellular adhesion molecule 1 (ICAM-1)

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of inflammation

  14. Intracellular adhesion molecule 1 (ICAM-1)

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of inflammation

  15. Vascular cell adhesion protein 1 (VCAM-1)

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of inflammation

  16. Vascular cell adhesion protein 1 (VCAM-1)

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of inflammation

  17. Insulin

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of glucose metabolism

  18. Insulin

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of glucose metabolism

  19. Hemoglobin A1c

    Time frame: Blood collection cycle 1 (1989-1990)

    Biomarkers of glucose metabolism

  20. Hemoglobin A1c

    Time frame: Blood collection cycle 2 (2000-2001)

    Biomarkers of glucose metabolism

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2009
Study completion
2009
First posted
Jun 2, 2017
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.