NCT01279317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 3, 2011

Completed
Last Updated

October 3, 2011

Status Verified

August 1, 2011

Enrollment Period

6 months

First QC Date

January 17, 2011

Results QC Date

July 20, 2011

Last Update Submit

August 25, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

vinegar co-ingestion

EXPERIMENTAL

25 ml vinegar is added to glucose containing beverage

Dietary Supplement: vinegar co-ingestion

Placebo co-ingestion

PLACEBO COMPARATOR

25 ml vinegar is substituted by 25 ml water

Dietary Supplement: placebo co-ingestion

Interventions

placebo co-ingestionDIETARY_SUPPLEMENT

25 ml water co-ingested with a glucose-containing beverage

Placebo co-ingestion
vinegar co-ingestionDIETARY_SUPPLEMENT

25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage

Also known as: vinegar, acetic acid
vinegar co-ingestion

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male type 2 diabetes
  • overweight or obese
  • yrs

You may not qualify if:

  • incident cardiovascular events during last year
  • peptic ulcer, duodenal ulcer, oesophageal reflux
  • antacids, H2 receptor blocker, proton pump inhibitors, NSAIDS, prokinetic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Results Point of Contact

Title
Drs. Jan-Willem van Dijk
Organization
Maastricht University Medical Centre

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 3, 2011

Results First Posted

October 3, 2011

Record last verified: 2011-08

Locations