NCT02309424

Brief Summary

This open, randomized, cross-over, placebo-controlled study aims to investigate the effects of vinegar on glucose metabolism, endothelial function and circulating lipid levels in subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous difference technique.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable type-2-diabetes

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

July 1, 2008

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

5.4 years

First QC Date

December 1, 2014

Last Update Submit

December 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle glucose uptake following meal ingestion (area under the glucose uptake versus time curve-AUC)

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

Secondary Outcomes (7)

  • Plasma glucose levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma insulin levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma triglyceride levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma NEFA levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • Plasma glycerol levels following meal ingestion (area under the plasma concentration versus time curve-AUC)

    0, 30, 60, 90, 120, 180, 240, 300 min postmeal

  • +2 more secondary outcomes

Study Arms (2)

Vinegar

ACTIVE COMPARATOR

0,50mmol vinegar (6% acetic acid)

Dietary Supplement: Vinegar

Placebo

PLACEBO COMPARATOR

50 ml water

Other: Placebo

Interventions

VinegarDIETARY_SUPPLEMENT

0,50mmol vinegar (6% acetic acid)

Vinegar
PlaceboOTHER

50 ml water

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with impaired glucose tolerance or newly diagnosed type 2 diabetes before the initiation of medication therapy
  • Recreationally active
  • With stable body weight and diet during the last two months.

You may not qualify if:

  • Any systemic disease (besides glucose abnormalities)
  • Any medication therapy
  • Diabetic complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mitrou P, Petsiou E, Papakonstantinou E, Maratou E, Lambadiari V, Dimitriadis P, Spanoudi F, Raptis SA, Dimitriadis G. Vinegar Consumption Increases Insulin-Stimulated Glucose Uptake by the Forearm Muscle in Humans with Type 2 Diabetes. J Diabetes Res. 2015;2015:175204. doi: 10.1155/2015/175204. Epub 2015 May 6.

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

Study Officials

  • George D Dimitriadis, Professor

    Attikon Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, MD, PhD

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 5, 2014

Study Start

July 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12