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

NCT ID: NCT01766700

Last Updated: 2015-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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No calorie beverages

2 no calorie beverages per day.

Group Type EXPERIMENTAL

2 no calorie beverages per day

Intervention Type BEHAVIORAL

Weekly and monthly lifestyle weight loss/maintenance classes.

Water

2 water beverages per day.

Group Type ACTIVE_COMPARATOR

2 water beverages per day

Intervention Type BEHAVIORAL

Weekly and monthly lifestyle weight loss/maintenance classes.

Interventions

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2 no calorie beverages per day

Weekly and monthly lifestyle weight loss/maintenance classes.

Intervention Type BEHAVIORAL

2 water beverages per day

Weekly and monthly lifestyle weight loss/maintenance classes.

Intervention Type BEHAVIORAL

Other Intervention Names

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2 non-nutritive sweetened beverages per day water only group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Gary Foster, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Peters JC, Wyatt HR, Foster GD, Pan Z, Wojtanowski AC, Vander Veur SS, Herring SJ, Brill C, Hill JO. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program. Obesity (Silver Spring). 2014 Jun;22(6):1415-21. doi: 10.1002/oby.20737.

Reference Type DERIVED
PMID: 24862170 (View on PubMed)

Other Identifiers

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12-1063

Identifier Type: -

Identifier Source: org_study_id

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