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

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ClinicalTrials.gov Identifier: NCT03173586
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Vasanti Malik, Harvard School of Public Health

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.

Condition or disease Intervention/treatment
Biomarkers 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.

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Study Type : Observational
Actual Enrollment : 33000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women
Actual Study Start Date : September 16, 1999
Actual Primary Completion Date : March 31, 2009
Actual Study Completion Date : March 31, 2009

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 Name: Artificially sweetened beverage (ASB), juice




Primary Outcome Measures :
  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 Outcome Measures :
  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


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Our analysis was based on a cohort of female registered nurses.
Accepts Healthy Volunteers:   Yes
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
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173586


Locations
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United States, Massachusetts
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health
Investigators
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Principal Investigator: Vasanti Malik, ScD Research Scientist
Publications:

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Responsible Party: Vasanti Malik, Research Scientist, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03173586    
Other Study ID Numbers: 1999-P-011114
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are de-identified

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vasanti Malik, Harvard School of Public Health:
Sugar sweetened beverage, biomarker