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

Obesity Clinical Trial

Official title:

The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766700
• Other study ID #: 12-1063
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: May 27, 2015
• Start date: September 2012
• Est. completion date: August 2014

Study information

• Verified date: May 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: August 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• 2 no calorie beverages per day
Weekly and monthly lifestyle weight loss/maintenance classes.
• 2 water beverages per day
Weekly and monthly lifestyle weight loss/maintenance classes.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Health and Wellness Center	Aurora	Colorado
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Data will be measured at 12 weeks.	No
Secondary	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.		Data will be collected at end of study.	No