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Zero Calorie Drink Products (GGT)

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ClinicalTrials.gov Identifier: NCT00525694
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Brief 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. 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 or disease Intervention/treatment Phase
Obesity Other: Glucose tolerance test Other: glucose tolerance test solution Other: Diet Coke Other: Coke Zero Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products
Study Start Date : February 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525694


Locations
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: James Hays, MD Christiana Care Health Services

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT00525694     History of Changes
Other Study ID Numbers: CCC27009
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Pharmaceutical Solutions
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents