BiomarkersNCT03173586
Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women
An observational study of Biomarkers, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Biomarkers
- What is being tested?
- Sugar sweetened beverage (SSB)
- How many people
- 33,000 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 1999to 31 Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
About this study
Official title: Association Between 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.
Read the 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.
- Conditions
- Biomarkers
- Being tested
- Sugar sweetened beverage (SSB)
- Keywords
- Sugar sweetened beverage, biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar sweetened beverage (SSB)Other
Also called Artificially sweetened beverage (ASB), juice
This is an observational study examining sugar sweetened beverage intake in relation to biomarkers in the NHS.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sugar sweetened beverage (SSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetuin-A
Biomarkers of liver function
Measured: Blood collection cycle 1 (1989-1990)
Fetuin-A
Biomarkers of liver function
Measured: Blood collection cyle 2 (2000-2001)
Alanine transaminase
Biomarkers of liver function
Measured: Blood collection cycle 1 (1989-1990)
Alanine transaminase
Biomarkers of liver function
Measured: Blood collection cyle 2 (2000-2001)
Gamma-glutamyl transferase
Biomarkers of liver function
Measured: Blood collection cycle 1 (1989-1990)
Gamma-glutamyl transferase
Biomarkers of liver function
Measured: Blood collection cyle 2 (2000-2001)
Secondary outcomes (20)
Triglycerides
Biomarkers of lipid metabolism
Measured: Blood collection cycle 1 (1989-1990)
Triglycerides
Biomarkers of lipid metabolism
Measured: Blood collection cycle 2 (2000-2001)
High-density lipoprotein cholesterol (HDL-C)
Biomarkers of lipid metabolism
Measured: Blood collection cycle 1 (1989-1990)
High-density lipoprotein cholesterol (HDL-C)
Biomarkers of lipid metabolism
Measured: Blood collection cycle 2 (2000-2001)
Low-density lipoprotein cholesterol (LDL-C)
Biomarkers of lipid metabolism
Measured: Blood collection cycle 1 (1989-1990)
Low-density lipoprotein cholesterol (LDL-C)
Biomarkers of lipid metabolism
Measured: Blood collection cycle 2 (2000-2001)
Total cholesterol
Biomarkers of lipid metabolism
Measured: Blood collection cycle 1 (1989-1990)
Total cholesterol
Biomarkers of lipid metabolism
Measured: Blood collection cycle 2 (2000-2001)
Total cholesterol/HDL-C ratio
Biomarkers of lipid metabolism
Measured: Blood collection cycle 1 (1989-1990)
Total cholesterol/HDL-C ratio
Biomarkers of lipid metabolism
Measured: Blood collection cycle 2 (2000-2001)
C-reactive protein (CRP)
Biomarkers of inflammation
Measured: Blood collection cycle 1 (1989-1990)
C-reactive protein (CRP)
Biomarkers of inflammation
Measured: Blood collection cycle 2 (2000-2001)
Intracellular adhesion molecule 1 (ICAM-1)
Biomarkers of inflammation
Measured: Blood collection cycle 1 (1989-1990)
Intracellular adhesion molecule 1 (ICAM-1)
Biomarkers of inflammation
Measured: Blood collection cycle 2 (2000-2001)
Vascular cell adhesion protein 1 (VCAM-1)
Biomarkers of inflammation
Measured: Blood collection cycle 1 (1989-1990)
Vascular cell adhesion protein 1 (VCAM-1)
Biomarkers of inflammation
Measured: Blood collection cycle 2 (2000-2001)
Insulin
Biomarkers of glucose metabolism
Measured: Blood collection cycle 1 (1989-1990)
Insulin
Biomarkers of glucose metabolism
Measured: Blood collection cycle 2 (2000-2001)
Hemoglobin A1c
Biomarkers of glucose metabolism
Measured: Blood collection cycle 1 (1989-1990)
Hemoglobin A1c
Biomarkers of glucose metabolism
Measured: Blood collection cycle 2 (2000-2001)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start16 Sep 1999
- Primary completion31 Mar 2009
- Study completion31 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for BiomarkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasanti Malik, Harvard School of Public Health (HSPH)
- Investigators
- Vasanti Malik, ScD, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173586
- Sponsor's protocol ID
- 1999-P-011114
- Status last verified
- May 2017
- First submitted
- 26 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are de-identified
Publications
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.
PubMed 20693348Xi 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.
PubMed 25735740de 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.
PubMed 22412070Bazzano 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.
PubMed 18390796Schulze 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.
PubMed 15328324Nettleton 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.
PubMed 19151203de 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.
PubMed 21430119Willett 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.
PubMed 4014201Salvini 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.
PubMed 2621022Ley 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.
PubMed 24105100Nimptsch 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.
PubMed 21543531Sun 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.
PubMed 22923470Malik 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.
PubMed 23966427Liu 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.
PubMed 11864854Fung 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.
PubMed 19211821
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Sugar Sweetened Beverage Intake and Biomarkers of Cardiometabolic Risk in US Women
- ClinicalTrials.gov ID
- NCT03173586
- Acronym / sponsor ID
- 1999-P-011114
- Conditions
- Biomarkers
- Keywords
- Sugar sweetened beverage, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33,000 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 16 Sep 1999 (actual)
- Primary completion
- 31 Mar 2009 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NHS | – | Other: 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar sweetened beverage (SSB)Also: Artificially sweetened beverage (ASB), juiceThis is an observational study examining sugar sweetened beverage intake in relation to biomarkers in the NHS. | Other | NHS |
Primary outcome
Fetuin-A
Time frame: Blood collection cycle 1 (1989-1990)
Biomarkers of liver function
Fetuin-A
Time frame: Blood collection cyle 2 (2000-2001)
Biomarkers of liver function
Alanine transaminase
Time frame: Blood collection cycle 1 (1989-1990)
Biomarkers of liver function
Alanine transaminase
Time frame: Blood collection cyle 2 (2000-2001)
Biomarkers of liver function
Gamma-glutamyl transferase
Time frame: Blood collection cycle 1 (1989-1990)
Biomarkers of liver function
Gamma-glutamyl transferase
Time frame: Blood collection cyle 2 (2000-2001)
Biomarkers of liver function
20 secondary outcomes
Triglycerides
Time frame: Blood collection cycle 1 (1989-1990)
Triglycerides
Time frame: Blood collection cycle 2 (2000-2001)
High-density lipoprotein cholesterol (HDL-C)
Time frame: Blood collection cycle 1 (1989-1990)
High-density lipoprotein cholesterol (HDL-C)
Time frame: Blood collection cycle 2 (2000-2001)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Blood collection cycle 1 (1989-1990)
Low-density lipoprotein cholesterol (LDL-C)
Time frame: Blood collection cycle 2 (2000-2001)
Total cholesterol
Time frame: Blood collection cycle 1 (1989-1990)
Total cholesterol
Time frame: Blood collection cycle 2 (2000-2001)
Total cholesterol/HDL-C ratio
Time frame: Blood collection cycle 1 (1989-1990)
Total cholesterol/HDL-C ratio
Time frame: Blood collection cycle 2 (2000-2001)
C-reactive protein (CRP)
Time frame: Blood collection cycle 1 (1989-1990)
C-reactive protein (CRP)
Time frame: Blood collection cycle 2 (2000-2001)
Intracellular adhesion molecule 1 (ICAM-1)
Time frame: Blood collection cycle 1 (1989-1990)
Intracellular adhesion molecule 1 (ICAM-1)
Time frame: Blood collection cycle 2 (2000-2001)
Vascular cell adhesion protein 1 (VCAM-1)
Time frame: Blood collection cycle 1 (1989-1990)
Vascular cell adhesion protein 1 (VCAM-1)
Time frame: Blood collection cycle 2 (2000-2001)
Insulin
Time frame: Blood collection cycle 1 (1989-1990)
Insulin
Time frame: Blood collection cycle 2 (2000-2001)
Hemoglobin A1c
Time frame: Blood collection cycle 1 (1989-1990)
Hemoglobin A1c
Time frame: Blood collection cycle 2 (2000-2001)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Background: PubMed 20693348Malik 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.
- Background: PubMed 25735740Xi 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.
- Background: PubMed 22412070de 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.
- Background: PubMed 18390796Bazzano 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.
- Background: PubMed 15328324Schulze 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.
- Background: PubMed 19151203Nettleton 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.
- Background: PubMed 21430119de 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.
- Background: PubMed 4014201Willett 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.
- Background: PubMed 2621022Salvini 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.
- Background: PubMed 24105100Ley 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.
- Background: PubMed 21543531Nimptsch 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.
- Background: PubMed 22923470Sun 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.
- Individual participant dataSharing planned: No. Data are de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasanti Malik, ScD principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers, run by Harvard School of Public Health (HSPH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetuin-A (time frame: Blood collection cycle 1 (1989-1990)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173586, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.