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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
  Purpose
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.

Condition Intervention
Obesity Behavioral: 2 no calorie beverages per day Behavioral: 2 water beverages per day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • 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. ]

Enrollment: 308
Study Start Date: September 2012
Study Completion Date: August 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No calorie beverages
2 no calorie beverages per day.
Behavioral: 2 no calorie beverages per day
Weekly and monthly lifestyle weight loss/maintenance classes.
Other Name: 2 non-nutritive sweetened beverages per day
Active Comparator: Water
2 water beverages per day.
Behavioral: 2 water beverages per day
Weekly and monthly lifestyle weight loss/maintenance classes.
Other Name: water only group

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT01766700


Locations
United States, Colorado
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, United States, 80022
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
University of Colorado, Denver
Temple University
Investigators
Principal Investigator: James Hill, PhD University of Colorado, Denver
Principal Investigator: Gary Foster, PhD Temple University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01766700     History of Changes
Other Study ID Numbers: 12-1063
First Submitted: October 3, 2012
First Posted: January 11, 2013
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Colorado, Denver:
Obesity, weight loss, weight maintenance

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms