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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimber Stanhope, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01103921
First received: April 13, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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
Dyslipidemia
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.


Enrollment: 214
Study Start Date: October 2008
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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
Aspartame
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103921

Locations
United States, California
Clinical Research Center
Sacramento, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
Investigators
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
ClinicalTrials.gov Identifier: NCT01103921     History of Changes
Other Study ID Numbers: 200715772, R01HL091333, R01HL107256
Study First Received: April 13, 2010
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
sugar
fructose
glucose
HFCS
metabolism

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Dyslipidemias
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on October 01, 2014