Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
1
glucose tolerance test solution
Intervention: Glucose tolerance test (Other)
1
glucose tolerance test solution
Intervention: glucose tolerance test solution (Other)
2
Diet Coke
Intervention: Diet Coke (Other)
3.
Coke Zero
Intervention: Coke Zero (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported