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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: 2 water beverages per day; Behavioral: 2 no calorie beverages per day

• Registration Number: NCT01766700
• Lead Sponsor: University of Colorado, Denver

Brief 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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2013-07
• Study Completion: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water	2 water beverages per day	2 water beverages per day.
No calorie beverages	2 no calorie beverages per day	2 no calorie beverages per day.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Colorado Anschutz Health and Wellness Center; 🇺🇸 Aurora, Colorado, United States