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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165853
First Posted: July 20, 2010
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, Davis
  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 (Participant, 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:


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


Secondary Outcome Measures:
  • Insulin sensitivity index [ Time Frame: Baseline and 8-week intervention ]
    Insulin sensitivity is assessed using the deuterated glucose disposal method.


Enrollment: 32
Study Start Date: July 2005
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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