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

Metabolic Syndrome Clinical Trial

— DRS  

Official title:

Effects of 2-weeks Fructose & HFCS Consumption on Dyslipidemia & Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103921
• Other study ID #: 200715772
• Secondary ID: R01HL091333R01HL
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: May 25, 2017
• Start date: October 2008
• Est. completion date: January 2014

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• Glucose
25% dose at 2-week intervention assigned to subjects.
• Fructose
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
• High-Fructose Corn Syrup
25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
• No sugar (Aspartame)
0% dose at 2-week intervention assigned to subjects.

Locations

Country	Name	City	State
United States	Clinical Research Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour triglyceride area under the curve	32 serial blood samples are collected over a 24 hour period.	Baseline and 2-week intervention
Secondary	Insulin sensitivity index	Insulin sensitivity is assessed using the deuterated glucose disposal method.	Baseline and 2-week intervention