The Metabolic Effects of Consuming Sugar-Sweetened Beverages for Two Weeks (DRS)
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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 |
- 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.
- 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
|
|
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 |
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| Contact: Kimber L Stanhope, Ph.D, R.D. | (530) 752-6553 | klstanhope@ucdavis.edu |
| United States, California | |
| Clinical Research Center | Recruiting |
| Sacramento, California, United States, 95655 | |
| Contact 916-843-9441 | |
| 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: | March 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
sugar fructose glucose HFCS metabolism |
Additional relevant MeSH terms:
|
Insulin Resistance Dyslipidemias Metabolic Syndrome X Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on May 21, 2013