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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01103921
Acronym
DRS
Enrollment
214
Registered
2010-04-15
Start date
2008-10-31
Completion date
2014-01-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Insulin Resistance, Metabolic Syndrome

Keywords

sugar, fructose, glucose, HFCS, metabolism

Brief 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.

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.

Interventions

OTHERGlucose

25% dose at 2-week intervention assigned to subjects.

OTHERFructose

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

OTHERHigh-Fructose Corn Syrup

25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.

OTHERNo sugar (Aspartame)

0% dose at 2-week intervention assigned to subjects.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
24-hour triglyceride area under the curveBaseline and 2-week intervention32 serial blood samples are collected over a 24 hour period.

Secondary

MeasureTime frameDescription
Insulin sensitivity indexBaseline and 2-week interventionInsulin sensitivity is assessed using the deuterated glucose disposal method.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026