Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks

Not Applicable

Completed

• Conditions: Dyslipidemia; Metabolic Syndrome; Insulin Resistance
• Interventions: Other: Glucose; Other: Fructose

• Registration Number: NCT01165853
• Lead Sponsor: University of California, Davis

Brief Summary

The purpose of this study is compare the effects of consuming glucose- and fructose-sweetened beverages on appetite, body weight, body fat, and the amount of energy the body burns as well as effects on blood pressure, hormones, blood triglycerides and cholesterol, and the body's sensitivity to the insulin.

Detailed Description

The study is designed as a prospective, blinded diet intervention study during which the participants consume either fructose- or glucose-sweetened beverages (25% of energy) with meals. Experimental procedures, including 24-hour serial blood sampling, 26-h stable isotoped infusions, post-heparin blood collection, gluteal biopsies, metabolic rate monitoring, computed tomography scans of the abdomen, and Oral Glucose Tolerance and Disposal Tests, are performed during baseline and at the end of a 10-week intervention period at the UC Davis School of Medicine/Sacramento Veterans Affairs Medical Center Clinical Research Center (CCRC). During the 2-week inpatient baseline period, subjects are served energy balanced diets containing 15% of energy as protein, 30% as fat, and 55% as complex carbohydrate. Following the baseline period, the subjects reside at home for 8 weeks and consume their usual ad libitum diet along with 25% of energy requirements as fructose- or glucose-sweetened beverages. Subjects then return to the CCRC for the 2-week inpatient intervention period at the end of the study and are served energy-balanced diets containing 15% of energy as protein, 30% as fat, 30% as complex carbohydrate and 25% of energy as fructose- or glucose-sweetened beverage.

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2007-11
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-20
• Study Completion: 2012-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Self-report of stable body weight
• Women were post-menopausal based on a self-report of no menstruation for at least one year

Exclusion Criteria

• evidence of diabetes
• renal or hepatic disease
• fasting serum TG concentrations >400 mg/dl
• hypertension (>140/90 mg Hg)
• surgery for weight loss
• individuals who smoked
• reported exercise of more than 3.5 hours/week at a level more vigorous than walking
• having used thyroid, lipid-lowering, glucose-lowering, anti-hypertensive, anti-depressant, or weight loss medications
• habitual ingestion of more than one sugar-sweetened beverage/day or more than two alcoholic beverages/day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose	Glucose	-
Fructose	Fructose	-

Primary Outcome Measures

Name	Time	Method
24-hour triglyceride area under the curve	Baseline and 8-week intervention	32 serial blood samples are collected over a 24 hour period.

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity index	Baseline and 8-week intervention	Insulin sensitivity is assessed using the deuterated glucose disposal method.

Trial Locations

Locations (1)

Clinical Research Center; 🇺🇸 Sacramento, California, United States