ObesityNCT01766700
The Role of No-Calorie Beverages Within a Weight Loss Program
A study testing 2 no calorie beverages per day and 2 water beverages per day in people with Obesity, run by University of Colorado, Denver at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 2 no calorie beverages per day and 2 water beverages per day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index: 27 - 40 kg/m2
- Must drink no calorie, sweetened drinks
Who cannot join
- Cardiovascular disease
- Uncontrolled blood pressure
- Smoker
- Medications that affecting metabolism
- Oral steroids
- History of stroke or seizures
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, 80022
Temple University
Philadelphia, Pennsylvania, 19140
About this study
Official title: The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- 2 no calorie beverages per day, 2 water beverages per day
- Keywords
- Obesity, weight loss, weight maintenance
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 no calorie beverages per dayBehavioural
Also called 2 non-nutritive sweetened beverages per day
Weekly and monthly lifestyle weight loss/maintenance classes.
2 water beverages per dayBehavioural
Also called water only group
Weekly and monthly lifestyle weight loss/maintenance classes.
| Study group | Role | What they receive |
|---|---|---|
| No calorie beverages | Experimental | 2 no calorie beverages per day. Receives: Behavioral: 2 no calorie beverages per day |
| Water | Active comparator | 2 water beverages per day. Receives: Behavioral: 2 water beverages per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Data will be collected at end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University
- Responsible party
- Sponsor
- Investigators
- James Hill, PhD, Principal investigator, University of Colorado, DenverGary Foster, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766700
- Sponsor's protocol ID
- 12-1063
- Status last verified
- May 2015
- First submitted
- 3 Oct 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24862170
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance
- ClinicalTrials.gov ID
- NCT01766700
- Acronym / sponsor ID
- 12-1063
- Conditions
- Obesity
- Keywords
- Obesity, weight loss, weight maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Temple University
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No calorie beverages | Experimental | Behavioral: 2 no calorie beverages per day2 no calorie beverages per day. |
| Water | Active comparator | Behavioral: 2 water beverages per day2 water beverages per day. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index: 27 - 40 kg/m2
- Must drink no calorie, sweetened drinks
Key exclusion criteria (15 listed)
- Cardiovascular disease
- Uncontrolled blood pressure
- Smoker
- Medications that affecting metabolism
- Oral steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 no calorie beverages per dayAlso: 2 non-nutritive sweetened beverages per dayWeekly and monthly lifestyle weight loss/maintenance classes. | Behavioural | No calorie beverages |
| 2 water beverages per dayAlso: water only groupWeekly and monthly lifestyle weight loss/maintenance classes. | Behavioural | Water |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 24862170Peters 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Hill, PhD principal investigator
University of Colorado, Denver
Gary Foster, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 no calorie beverages per day and 2 water beverages per day in people with Obesity, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.