The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks (DRS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of California, Davis.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Kimber Stanhope, University of California, Davis Identifier:
First received: April 13, 2010
Last updated: March 12, 2012
Last verified: March 2012

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.

Condition Intervention
Metabolic Syndrome
Insulin Resistance
Other: Glucose
Other: Fructose
Other: High-Fructose Corn Syrup
Other: No sugar (Aspartame)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 24-hour triglyceride area under the curve [ Time Frame: Baseline and 2-week intervention ] [ Designated as safety issue: No ]
    32 serial blood samples are collected over a 24 hour period.

Secondary Outcome Measures:
  • Insulin sensitivity index [ Time Frame: Baseline and 2-week intervention ] [ Designated as safety issue: No ]
    Insulin sensitivity is assessed using the deuterated glucose disposal method.

Estimated Enrollment: 200
Study Start Date: October 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Glucose Other: Glucose
25% dose at 2-week intervention assigned to subjects.
Other Name: Sugar
Fructose Other: Fructose
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
Other Name: Sugar
High-Fructose Corn Syrup Other: High-Fructose Corn Syrup
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
Other Name: HFCS
No sugar
Other: No sugar (Aspartame)
0% dose at 2-week intervention assigned to subjects.
Other Name: Non-caloric sweetener

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.


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01103921

Contact: Kimber L Stanhope, Ph.D, R.D. (530) 752-6553

United States, California
Clinical Research Center Recruiting
Sacramento, California, United States, 95655
Contact    916-843-9441      
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Peter J Havel, D.V.M University of California, Davis
Study Director: Kimber L Stanhope, Ph.D, R.D. University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Kimber Stanhope, Associate Project Scientist, University of California, Davis Identifier: NCT01103921     History of Changes
Other Study ID Numbers: 200715772, R01HL091333, R01HL107256
Study First Received: April 13, 2010
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:

Additional relevant MeSH terms:
Insulin Resistance
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders processed this record on April 17, 2014