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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Temple University
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01766700
First received: October 3, 2012
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  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: 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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated 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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01766700     History of Changes
Other Study ID Numbers: 12-1063
Study First Received: October 3, 2012
Last Updated: April 3, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013