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

Metabolic Syndrome Clinical Trial

— IPOP  

Official title:

Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks on Hormones and Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165853
• Other study ID #: 200412368
• Secondary ID: R01HL075675
• Status: Completed
• Phase: N/A
• First received: July 16, 2010
• Last updated: May 25, 2017
• Start date: July 2005
• Est. completion date: July 2012

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2012
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Glucose
25% dose at 8-week intervention assigned to subjects.
• Fructose
25% dose at 8-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 8-week intervention
Secondary	Insulin sensitivity index	Insulin sensitivity is assessed using the deuterated glucose disposal method.	Baseline and 8-week intervention