Â
Zero Calorie Drink Products, Recruiting Patients for Study
This study is currently recruiting participants. Verified by Christiana Care Health Services September 2007
Sponsored by:
Christiana Care Health Services
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00525694
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.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Crossover Assignment
Official Title: Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products
Further study details as provided by Christiana Care Health Services:
Study start: February 2007
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00525694
James Hays, MD, Principal Investigator, Christiana Care Health System
More Information
Study ID Numbers: CCC27009
Last Updated: September 5, 2007
Record first received: September 5, 2007
ClinicalTrials.gov Identifier: NCT00525694 Health Authority: United States: Institutional Review Board
