Zero Calorie Drink Products (GGT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Other: Glucose tolerance test Other: glucose tolerance test solution Other: Diet Coke Other: Coke Zero |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2007 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
glucose tolerance test solution
|
Other: Glucose tolerance test
10 ounces glucose tolerance test solution
Other: glucose tolerance test solution
75 grams glucose load
|
|
2
Diet Coke
|
Other: Diet Coke
10 ounces of Diet Coke
|
|
3.
Coke Zero
|
Other: Coke Zero
10 ounces of Coke Zero
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with chronic illnesses, especially diabetes
Contacts and Locations| United States, Delaware | |
| Christiana Care Health System | |
| Newark, Delaware, United States, 19718 | |
| Principal Investigator: | James Hays, MD | Christiana Care Health System |
More Information
No publications provided
| Responsible Party: | Angela DiSabatino, RN, MS, Manager, Cardiovascular Clinical Trials Program, Christiana Care Health Services |
| ClinicalTrials.gov Identifier: | NCT00525694 History of Changes |
| Other Study ID Numbers: | CCC27009 |
| Study First Received: | September 5, 2007 |
| Last Updated: | March 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013