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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01766700

Enrollment

308

Registered

2013-01-11

Start date

2012-09-30

Completion date

2014-08-31

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, weight loss, weight maintenance

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.

Interventions

BEHAVIORAL2 no calorie beverages per day

Weekly and monthly lifestyle weight loss/maintenance classes.

BEHAVIORAL2 water beverages per day

Weekly and monthly lifestyle weight loss/maintenance classes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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.	Data will be measured at 12 weeks.

Secondary

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.	Data will be collected at end of study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026