Zero Calorie Drink Products (GGT)

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00525694
First received: September 5, 2007
Last updated: March 24, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  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 April 15, 2014