Type 2 Diabetes MellitusNCT01279317
Vinegar Co-ingestion in Type 2 Diabetes
A study testing vinegar co-ingestion in people with Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- vinegar co-ingestion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male type 2 diabetes
- overweight or obese
- 40-70 yrs
Who cannot join
- incident cardiovascular events during last year
- peptic ulcer, duodenal ulcer, oesophageal reflux
- antacids, H2 receptor blocker, proton pump inhibitors, NSAIDS, prokinetic agents
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6200 MD
About this study
Official title: The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- placebo co-ingestion, vinegar co-ingestion
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo co-ingestionDietary supplement
25 ml water co-ingested with a glucose-containing beverage
vinegar co-ingestionDietary supplement
Also called vinegar, acetic acid
25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
| Study group | Role | What they receive |
|---|---|---|
| vinegar co-ingestion | Experimental | 25 ml vinegar is added to glucose containing beverage Receives: Dietary Supplement: vinegar co-ingestion |
| Placebo co-ingestion | Placebo comparator | 25 ml vinegar is substituted by 25 ml water Receives: Dietary Supplement: placebo co-ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279317
- Sponsor's protocol ID
- MEC 10-3-035
- Status last verified
- Aug 2011
- First submitted
- 17 Jan 2011
- Last updated
- 3 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vinegar Co-ingestion on Postprandial Glucose Control in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT01279317
- Acronym / sponsor ID
- MEC 10-3-035
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Posted 3 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vinegar co-ingestion | Experimental | Dietary Supplement: vinegar co-ingestion25 ml vinegar is added to glucose containing beverage |
| Placebo co-ingestion | Placebo comparator | Dietary Supplement: placebo co-ingestion25 ml vinegar is substituted by 25 ml water |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male type 2 diabetes
- overweight or obese
- 40-70 yrs
Key exclusion criteria (3 listed)
- incident cardiovascular events during last year
- peptic ulcer, duodenal ulcer, oesophageal reflux
- antacids, H2 receptor blocker, proton pump inhibitors, NSAIDS, prokinetic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo co-ingestion25 ml water co-ingested with a glucose-containing beverage | Dietary supplement | Placebo co-ingestion |
| vinegar co-ingestionAlso: vinegar, acetic acid25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage | Dietary supplement | vinegar co-ingestion |
Primary outcome
Postprandial Glycemic Incremental Area Under the Curve
Time frame: 2 hr
area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vinegar co-ingestion in people with Type 2 Diabetes Mellitus, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Glycemic Incremental Area Under the Curve (time frame: 2 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.