Back to resultsVinegar Co-ingestion in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
placebo co-ingestion
vinegar co-ingestion
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
vinegar co-ingestion
Placebo co-ingestion
Arm Description
25 ml vinegar is added to glucose containing beverage
25 ml vinegar is substituted by 25 ml water
Outcomes
Primary Outcome Measures
Postprandial Glycemic Incremental Area Under the Curve
area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages
Secondary Outcome Measures
Full Information
NCT ID
NCT01279317
First Posted
January 17, 2011
Last Updated
August 25, 2011
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01279317
Brief Title
Vinegar Co-ingestion in Type 2 Diabetes
Official Title
The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vinegar co-ingestion
Arm Type
Experimental
Arm Description
25 ml vinegar is added to glucose containing beverage
Arm Title
Placebo co-ingestion
Arm Type
Placebo Comparator
Arm Description
25 ml vinegar is substituted by 25 ml water
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo co-ingestion
Intervention Description
25 ml water co-ingested with a glucose-containing beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
vinegar co-ingestion
Other Intervention Name(s)
vinegar, acetic acid
Intervention Description
25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
Primary Outcome Measure Information:
Title
Postprandial Glycemic Incremental Area Under the Curve
Description
area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages
Time Frame
2 hr
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands
12. IPD Sharing Statement
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Vinegar Co-ingestion in Type 2 Diabetes
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