Trial Outcomes & Findings for Vinegar Co-ingestion in Type 2 Diabetes (NCT NCT01279317)

Last Updated: 2011-10-03

Results Overview

area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

2 hr

Results posted on

2011-10-03

Participant Flow

recruitment by advertisements in local newspaper

none applicable

Participant milestones

Participant milestones
Measure	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).	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).
Period 1 STARTED	6	6
Period 1 COMPLETED	6	6
Period 1 NOT COMPLETED	0	0
Washout STARTED	6	6
Washout COMPLETED	6	6
Washout NOT COMPLETED	0	0
Period 2 STARTED	6	6
Period 2 COMPLETED	6	6
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vinegar Co-ingestion in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vinegar Co-ingestion n=12 Participants All participants performed both intervention periods.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Netherlands	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hr

Population: all subjects completed study and are included in analysis

area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages

Outcome measures

Outcome measures
Measure	Vinegar Co-ingestion n=12 Participants	Placebo Co-ingestion n=12 Participants
Postprandial Glycemic Incremental Area Under the Curve	739 mmol/L / 2hr Standard Error 74	759 mmol/L / 2hr Standard Error 75

Adverse Events

Vinegar Co-ingestion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Drs. Jan-Willem van Dijk

Maastricht University Medical Centre

Phone: +31(0)433881394

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place