Zero Calorie Drink Products

NCT ID: NCT00525694

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

glucose tolerance test solution

Group Type OTHER

Glucose tolerance test

Intervention Type OTHER

10 ounces glucose tolerance test solution

glucose tolerance test solution

Intervention Type OTHER

75 grams glucose load

2

Diet Coke

Group Type OTHER

Diet Coke

Intervention Type OTHER

10 ounces of Diet Coke

3.

Coke Zero

Group Type OTHER

Coke Zero

Intervention Type OTHER

10 ounces of Coke Zero

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucose tolerance test

10 ounces glucose tolerance test solution

Intervention Type OTHER

glucose tolerance test solution

75 grams glucose load

Intervention Type OTHER

Diet Coke

10 ounces of Diet Coke

Intervention Type OTHER

Coke Zero

10 ounces of Coke Zero

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James Hays, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Christiana Care Health System

Newark, Delaware, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCC27009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.