- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279317
Vinegar Co-ingestion in Type 2 Diabetes
August 25, 2011 updated by: Maastricht University Medical Center
The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients
The main objective of this study is to assess the acute effect of co-ingested vinegar on postprandial plasma glucose levels in type 2 diabetes patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Plasma glucose and insulin concentrations are assessed over the 2 hr period following ingestion of carbohydrate-rich beverage with or without added vinegar.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6200 MD
- Maastricht University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male type 2 diabetes
- overweight or obese
- 40-70 yrs
Exclusion Criteria:
- incident cardiovascular events during last year
- peptic ulcer, duodenal ulcer, oesophageal reflux
- antacids, H2 receptor blocker, proton pump inhibitors, NSAIDS, prokinetic agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: vinegar co-ingestion
25 ml vinegar is added to glucose containing beverage
|
25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
Other Names:
|
|
Placebo Comparator: Placebo co-ingestion
25 ml vinegar is substituted by 25 ml water
|
25 ml water co-ingested with a glucose-containing beverage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Glycemic Incremental Area Under the Curve
Time Frame: 2 hr
|
area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages
|
2 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
January 17, 2011
First Submitted That Met QC Criteria
January 17, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
October 3, 2011
Last Update Submitted That Met QC Criteria
August 25, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 10-3-035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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