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Vinegar Co-ingestion in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01279317
First received: January 17, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Dietary Supplement: placebo co-ingestion
Dietary Supplement: vinegar co-ingestion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Postprandial Glycemic Incremental Area Under the Curve [ Time Frame: 2 hr ] [ Designated as safety issue: No ]
    area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages


Enrollment: 12
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vinegar co-ingestion
25 ml vinegar is added to glucose containing beverage
 Dietary Supplement: vinegar co-ingestion
25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
Other Names:
  • vinegar
  • acetic acid
Placebo Comparator: Placebo co-ingestion
25 ml vinegar is substituted by 25 ml water
 Dietary Supplement: placebo co-ingestion
25 ml water co-ingested with a glucose-containing beverage

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279317

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01279317     History of Changes
Other Study ID Numbers: MEC 10-3-035
Study First Received: January 17, 2011
Results First Received: July 20, 2011
Last Updated: August 25, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Retinol acetate
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013