Clinical trial NCT03173586: Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women
Official title: Association Between Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomarkers
Keywords: Sugar sweetened beverage, biomarker
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 33000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.

Primary outcomes:
measure: Fetuin-A
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Fetuin-A
timeFrame: Blood collection cyle 2 (2000-2001)
measure: Alanine transaminase
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Alanine transaminase
timeFrame: Blood collection cyle 2 (2000-2001)
measure: Gamma-glutamyl transferase
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Gamma-glutamyl transferase
timeFrame: Blood collection cyle 2 (2000-2001)
Secondary outcomes:
measure: Triglycerides
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Triglycerides
timeFrame: Blood collection cycle 2 (2000-2001)
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: Blood collection cycle 1 (1989-1990)
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Total cholesterol
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Total cholesterol
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Total cholesterol/HDL-C ratio
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Total cholesterol/HDL-C ratio
timeFrame: Blood collection cycle 2 (2000-2001)
measure: C-reactive protein (CRP)
timeFrame: Blood collection cycle 1 (1989-1990)
measure: C-reactive protein (CRP)
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Intracellular adhesion molecule 1 (ICAM-1)
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Intracellular adhesion molecule 1 (ICAM-1)
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Vascular cell adhesion protein 1 (VCAM-1)
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Vascular cell adhesion protein 1 (VCAM-1)
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Insulin
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Insulin
timeFrame: Blood collection cycle 2 (2000-2001)
measure: Hemoglobin A1c
timeFrame: Blood collection cycle 1 (1989-1990)
measure: Hemoglobin A1c
timeFrame: Blood collection cycle 2 (2000-2001)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard T.H. Chan School of Public Health
state: Massachusetts
Study officials:
affiliation: Research Scientist
name: Vasanti Malik, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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