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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kimber Stanhope, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01165853
First received: July 16, 2010
Last updated: March 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Insulin Resistance
Dyslipidemia
 Other: Glucose
Other: Fructose

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks on Hormones and Lipids

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 24-hour triglyceride area under the curve [ Time Frame: Baseline and 8-week intervention ] [ Designated as safety issue: No ]
    32 serial blood samples are collected over a 24 hour period.


Secondary Outcome Measures:
  • Insulin sensitivity index [ Time Frame: Baseline and 8-week intervention ] [ Designated as safety issue: No ]
    Insulin sensitivity is assessed using the deuterated glucose disposal method.


Enrollment: 32
Study Start Date: July 2005
Estimated Study Completion Date: July 2012
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Glucose Other: Glucose
25% dose at 8-week intervention assigned to subjects.
Other Name: sugar
Fructose Other: Fructose
25% dose at 8-week intervention assigned to subjects.
Other Name: sugar

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.

  Eligibility

Ages Eligible for Study:   40 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165853

Locations
United States, California
Clinical Research Center
Sacramento, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Peter J Havel, D.V.M. University of California, Davis
Study Director: Kimber L Stanhope, Ph.D, R.D. University of California, Davis
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kimber Stanhope, Associate Project Scientist, University of California, Davis
ClinicalTrials.gov Identifier: NCT01165853     History of Changes
Other Study ID Numbers: 200412368, R01HL075675
Study First Received: July 16, 2010
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Insulin Resistance
Dyslipidemias
Metabolic Syndrome X
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 16, 2013