Vinegar Co-ingestion in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279317
• Other study ID #: MEC 10-3-035
• Status: Completed
• Phase: N/A
• First received: January 17, 2011
• Last updated: August 25, 2011
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

Plasma glucose and insulin concentrations are assessed over the 2 hr period following ingestion of carbohydrate-rich beverage with or without added vinegar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• placebo co-ingestion
25 ml water co-ingested with a glucose-containing beverage
• vinegar co-ingestion
25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	2 hr	No