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

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ClinicalTrials.gov Identifier: NCT01165853
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE July 16, 2010
First Posted Date  ICMJE July 20, 2010
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE July 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01165853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
Insulin sensitivity index [ Time Frame: Baseline and 8-week intervention ]
Insulin sensitivity is assessed using the deuterated glucose disposal method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks
Official Title  ICMJE Effects of Consuming Sugar-Sweetened Beverages With Meals for 10 Weeks on Hormones and Lipids
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Metabolic Syndrome
  • Insulin Resistance
  • Dyslipidemia
Intervention  ICMJE
  • Other: Glucose
    25% dose at 8-week intervention assigned to subjects.
    Other Name: sugar
  • Other: Fructose
    25% dose at 8-week intervention assigned to subjects.
    Other Name: sugar
Study Arms  ICMJE
  • Glucose
    Intervention: Other: Glucose
  • Fructose
    Intervention: Other: Fructose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2010)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01165853
Other Study ID Numbers  ICMJE 200412368
R01HL075675 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
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
PRS Account University of California, Davis
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP