The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks (DRS)
May 25, 2017 updated by: University of California, Davis
Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance
The purpose of this study is to examine the effects of consumption of sugar-sweetened beverages on blood triglycerides and cholesterol, cholesterol concentrations, and the body's sensitivity to insulin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or HFCS-sweetened beverages (providing 10%, 17.5% or 25% of energy) with meals.
In addition, there will be two control groups, with one group consuming 0% sugar beverages sweetened with sucralose and the other consuming glucose-sweetened beverages at 25% of energy requirement.
Experimental procedures, including 24-hour serial blood sampling, post-heparin infusions, gluteal biopsies, Magnetic Resonance Imaging of the liver and the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 2-week intervention period at the UC Davis Clinical and Translational Science Center (CTSC) Clinical Research Center (CCRC).
During the inpatient periods, subjects are served energy balanced diets.
The diets provide 15% of energy as protein, 30% as fat, and 55% as carbohydrate.
During baseline testing, the carbohydrate content consists primarily of complex carbohydrate (>97%).
During intervention the 55% carbohydrate will consist of 10% sugar/45% complex, 17.5% sugar/37.5% complex, or 25% sugar/30% complex depending on the diet group to which the subject is assigned.
During the outpatient intervention periods, the subjects reside at home and are provided with fructose- or HFCS -sweetened beverages that are consumed with each meal along with a self-selected ad libitum (usual) diet.
Study Type
Interventional
Enrollment (Actual)
214
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95655
- Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index between 18-35
- Self report of stable body weight during the past six months
Exclusion Criteria:
- Diabetes Mellitus
- Evidence of liver disorder
- Evidence of kidney disorder
- Evidence of thyroid disorder
- Systolic blood pressure consistently over 160mmHg or diastolic blood pressure over 900mmHg
- Triglycerides > 400mg/dl
- LDL-C > 240mg/dl
- Hemoglobin < 8.5 g/dl
- Current, prior (within 2 months), or anticipated use of any hypolipidemic or anti-diabetic agents
- Use of Selective Serotonin Reuptake Inhibitors and anti-hypertensive medications
- Any other condition that, in the opinion of the investigators, would put subject at risk
- Strenuous exerciser
- Pregnant or lactating women
- Smoker
- Diet exclusions: food allergies, special dietary restrictions, habitual ingest of >2 alcoholic beverages/day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Glucose
|
25% dose at 2-week intervention assigned to subjects.
Other Names:
|
|
OTHER: Fructose
|
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
Other Names:
|
|
OTHER: High-Fructose Corn Syrup
|
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
Other Names:
|
|
OTHER: Aspartame
No sugar
|
0% dose at 2-week intervention assigned to subjects.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-hour triglyceride area under the curve
Time Frame: Baseline and 2-week intervention
|
32 serial blood samples are collected over a 24 hour period.
|
Baseline and 2-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin sensitivity index
Time Frame: Baseline and 2-week intervention
|
Insulin sensitivity is assessed using the deuterated glucose disposal method.
|
Baseline and 2-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter J Havel, D.V.M, University of California, Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sigala DM, Hieronimus B, Medici V, Lee V, Nunez MV, Bremer AA, Cox CL, Price CA, Benyam Y, Chaudhari AJ, Abdelhafez Y, McGahan JP, Goran MI, Sirlin CB, Pacini G, Tura A, Keim NL, Havel PJ, Stanhope KL. Consuming Sucrose- or HFCS-sweetened Beverages Increases Hepatic Lipid and Decreases Insulin Sensitivity in Adults. J Clin Endocrinol Metab. 2021 Oct 21;106(11):3248-3264. doi: 10.1210/clinem/dgab508.
- Hieronimus B, Medici V, Bremer AA, Lee V, Nunez MV, Sigala DM, Keim NL, Havel PJ, Stanhope KL. Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults. Metabolism. 2020 Nov;112:154356. doi: 10.1016/j.metabol.2020.154356. Epub 2020 Sep 9. Erratum In: Metabolism. 2021 Jun;119:154774.
- Stanhope KL, Medici V, Bremer AA, Lee V, Lam HD, Nunez MV, Chen GX, Keim NL, Havel PJ. A dose-response study of consuming high-fructose corn syrup-sweetened beverages on lipid/lipoprotein risk factors for cardiovascular disease in young adults. Am J Clin Nutr. 2015 Jun;101(6):1144-54. doi: 10.3945/ajcn.114.100461. Epub 2015 Apr 22.
- Tryon MS, Stanhope KL, Epel ES, Mason AE, Brown R, Medici V, Havel PJ, Laugero KD. Excessive Sugar Consumption May Be a Difficult Habit to Break: A View From the Brain and Body. J Clin Endocrinol Metab. 2015 Jun;100(6):2239-47. doi: 10.1210/jc.2014-4353. Epub 2015 Apr 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
January 1, 2014
Study Registration Dates
First Submitted
April 13, 2010
First Submitted That Met QC Criteria
April 13, 2010
First Posted (ESTIMATE)
April 15, 2010
Study Record Updates
Last Update Posted (ACTUAL)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200715772
- R01HL091333 (NIH)
- R01HL107256 (NIH)
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