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Completed

NCT Number: NCT01766700

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 no calorie beverages per day

Behavioral

Weekly and monthly lifestyle weight loss/maintenance classes.

Other names: 2 non-nutritive sweetened beverages per day

2 water beverages per day

Behavioral

Weekly and monthly lifestyle weight loss/maintenance classes.

Other names: water only group

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Temple University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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