ObesityGGTNCT00525694
Zero Calorie Drink Products
A study testing Glucose tolerance test, glucose tolerance test solution and Diet Coke in people with Obesity, run by Christiana Care Health Services at 1 site in United States.
Trial summary
This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Glucose tolerance test, glucose tolerance test solution and Diet Coke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Nov 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy,
- asymptomatic individuals for diabetes and pre-diabetes,
- especially for people at high risk of developing diabetes,
- such as those with a family history of diabetes,
- those who are overweight,
- and those who are more than 40 to 45 years old
Who cannot join
- Patients with chronic illnesses, especially diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19718
About this study
Official title: Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products
This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke.
- Conditions
- Obesity
- Being tested
- Glucose tolerance test, glucose tolerance test solution, Diet Coke, Coke Zero
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose tolerance testOther
10 ounces glucose tolerance test solution
glucose tolerance test solutionOther
75 grams glucose load
Diet CokeOther
10 ounces of Diet Coke
Coke ZeroOther
10 ounces of Coke Zero
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | glucose tolerance test solution Receives: Other: Glucose tolerance test; Other: glucose tolerance test solution |
| 2 | Other | Diet Coke Receives: Other: Diet Coke |
| 3. | Other | Coke Zero Receives: Other: Coke Zero |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Hays, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525694
- Sponsor's protocol ID
- CCC27009
- Acronym
- GGT
- Status last verified
- Jul 2016
- First submitted
- 5 Sep 2007
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products
- ClinicalTrials.gov ID
- NCT00525694
- Acronym / sponsor ID
- GGT / CCC27009
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 Sep 2007 (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.
This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Glucose tolerance test, Other: glucose tolerance test solutionglucose tolerance test solution |
| 2 | Other | Other: Diet CokeDiet Coke |
| 3. | Other | Other: Coke ZeroCoke Zero |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy,
- asymptomatic individuals for diabetes and pre-diabetes,
- especially for people at high risk of developing diabetes,
- such as those with a family history of diabetes,
- those who are overweight,
Key exclusion criteria (1 listed)
- Patients with chronic illnesses, especially diabetes
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 |
|---|---|---|
| Glucose tolerance test10 ounces glucose tolerance test solution | Other | 1 |
| glucose tolerance test solution75 grams glucose load | Other | 1 |
| Diet Coke10 ounces of Diet Coke | Other | 2 |
| Coke Zero10 ounces of Coke Zero | Other | 3. |
Primary outcome
to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus.
Time frame: 3 days
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 11 Jul 2016.
Related trials for Obesity
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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 Hays, MD principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose tolerance test, glucose tolerance test solution and Diet Coke in people with Obesity, run by Christiana Care Health Services at 1 site 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 6 inclusion and 1 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2016.