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The Role of No-Calorie Beverages Within a Weight Loss Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766700
First Posted: January 11, 2013
Last Update Posted: May 28, 2015
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:
Temple University
Information provided by (Responsible Party):
University of Colorado, Denver
October 3, 2012
January 11, 2013
May 28, 2015
September 2012
July 2013   (Final data collection date for primary outcome measure)
This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. [ Time Frame: Data will be measured at 12 weeks. ]
Same as current
Complete list of historical versions of study NCT01766700 on ClinicalTrials.gov Archive Site
This investigation is an equivalency trial to determine whether weight lost and maintained during the 1 year study differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers. [ Time Frame: Data will be collected at end of study. ]
Same as current
Not Provided
Not Provided
 
The Role of No-Calorie Beverages Within a Weight Loss Program
The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance
The no calorie drink study is looking for over 300 people to participate. The study is evaluating the effect of no calorie beverages on weight loss and weight maintained over time in people who drink diet beverages every day as compared to water only drinkers during the 1 year study period.
This investigation aims to test the hypothesis that the amount of weight lost and maintained over time in an intensive behavioral weight management program will be equivalent in subjects consuming beverages containing no calorie sweeteners as compared to water beverages.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Obesity
  • Behavioral: 2 no calorie beverages per day
    Weekly and monthly lifestyle weight loss/maintenance classes.
    Other Name: 2 non-nutritive sweetened beverages per day
  • Behavioral: 2 water beverages per day
    Weekly and monthly lifestyle weight loss/maintenance classes.
    Other Name: water only group
  • Experimental: No calorie beverages
    2 no calorie beverages per day.
    Intervention: Behavioral: 2 no calorie beverages per day
  • Active Comparator: Water
    2 water beverages per day.
    Intervention: Behavioral: 2 water beverages per day
Peters JC, Wyatt HR, Foster GD, Pan Z, Wojtanowski AC, Vander Veur SS, Herring SJ, Brill C, Hill JO. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program. Obesity (Silver Spring). 2014 Jun;22(6):1415-21. doi: 10.1002/oby.20737.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
August 2014
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body Mass Index: 27 - 40 kg/m2
  • Must drink no calorie, sweetened drinks

Exclusion Criteria

  • Cardiovascular disease
  • Uncontrolled blood pressure
  • Smoker
  • Medications that affecting metabolism
  • Oral steroids
  • History of stroke or seizures
  • Thyroid disease
  • Type 1 or 2 diabetes
  • Cushings syndrome
  • Renal disease
  • Liver disease
  • Cancer in the past 5 years
  • HIV
  • Active tuberculosis
  • Major psychiatric disorders
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01766700
12-1063
No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Temple University
Principal Investigator: James Hill, PhD University of Colorado, Denver
Principal Investigator: Gary Foster, PhD Temple University
University of Colorado, Denver
May 2015

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