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Completed

NCT Number: NCT01103921

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center

Sacramento, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose

Other

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

Other names: Sugar

Fructose

Other

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

Other names: Sugar

High-Fructose Corn Syrup

Other

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

Other names: HFCS

No sugar (Aspartame)

Other

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

Other names: Non-caloric sweetener

Primary outcomes

  1. 24-hour triglyceride area under the curve

    Time frame: Baseline and 2-week intervention

    32 serial blood samples are collected over a 24 hour period.

Secondary outcomes

  1. Insulin sensitivity index

    Time frame: Baseline and 2-week intervention

    Insulin sensitivity is assessed using the deuterated glucose disposal method.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: DRS

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2010
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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