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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.
Plasma glucose and insulin concentrations are assessed over the 2 hr period following ingestion of carbohydrate-rich beverage with or without added vinegar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vinegar co-ingestion | Experimental | 25 ml vinegar is added to glucose containing beverage |
|
| Placebo co-ingestion | Placebo Comparator | 25 ml vinegar is substituted by 25 ml water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo co-ingestion | Dietary Supplement | 25 ml water co-ingested with a glucose-containing beverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | Limburg | 6200 MD | Netherlands |
none applicable
recruitment by advertisements in local newspaper
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| ID | Title | Description |
|---|---|---|
| FG000 | Vinegar Co-ingestion First, Then Placebo Co-intestion | First acute experiment with vinegar-coingestion (1 day), after 1 week washout, experiment with placebo co-ingestion (1 day). |
| FG001 | Placebo Co-ingestion First, Then Vinegar Co-ingestion | First acute experiment with placebo-coingestion (1 day), after 1 week washout experiment with vinegar co-ingestion (1 day). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Washout |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vinegar Co-ingestion | All participants performed both intervention periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | all subjects completed study and are included in analysis | Posted | Jan 2011 | Mean | Standard Error | mmol/L / 2hr | 2 hr |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vinegar Co-ingestion | All participants performed both intervention periods. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drs. Jan-Willem van Dijk | Maastricht University Medical Centre | +31(0)433881394 | janwillem.vandijk@maastrichtuniversity.nl |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| ID | Term |
|---|---|
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| vinegar co-ingestion | Dietary Supplement | 25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage |
|
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D004700 | Endocrine System Diseases |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |