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

May 27, 2015 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80022
        • University of Colorado Anschutz Health and Wellness Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • water only group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Data will be measured at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Data will be collected at end of study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Temple University

Investigators

  • Principal Investigator: James Hill, PhD, University of Colorado, Denver
  • Principal Investigator: Gary Foster, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

January 9, 2013

First Posted (Estimate)

January 11, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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