HyperglycemiaNCT01857258
Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
A study testing Green Tea Concentrate in people with Hyperglycemia and Cardiovascular Disease, run by Ohio State University at 1 site in United States.
Trial summary
The objective of this study is to formulate and validate a green tea confection (i.e. "gummy" candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Cardiovascular Disease
- What is being tested?
- Green Tea Concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Apr 2016
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Plasma glucose <100 mg/dL
- Plasma total cholesterol <200 mg/dL
- Plasma triglycerides <140 mg/dL
- Blood pressure <140/90
- non-dietary supplement user for >2 months
- no use of medications known to affect carbohydrate metabolism,
- nonsmoker / never smoker
- no history of cardiovascular disease or gastrointestinal disorders
Who cannot join
- allergies or aversions to green tea and/or corn starch,
- excessive alcohol consumption (>3 drinks/d),
- >5 h/wk of aerobic activity
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to formulate and validate a green tea confection (i.e. "gummy" candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by developing a green tea-containing confection, examining its physiochemical properties and its inhibition of starch digestion, and then validating its vasoprotective activities in healthy humans by assessing its blood glucose-regulating activities.
Read the detailed description
The study involves validating a green tea confection (i.e. "gummy" candy) as a dietary strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by providing research participants 75 grams of carbohydrate in the form of a confection that contains no green tea concentrate or green tea concentrate at a level equivalent to approximately 3 cups of freshly brewed tea. Blood glucose and brachial artery flow-mediated dilation will be assessed at regular intervals during the 3 hour postprandial period to define the extent to which green tea attenuates postprandial increases in blood glucose and decreases in vascular function that otherwise occur in a hyperglycemia-dependent manner.
- Conditions
- Hyperglycemia, Cardiovascular Disease
- Being tested
- Green Tea Concentrate
- Keywords
- green tea, catechins, vascular endothelial function, postprandial hyperglycemia, oxidative stress
- Medical subject headings
- Hyperglycemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Tea ConcentrateDietary supplement
Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
| Study group | Role | What they receive |
|---|---|---|
| Green Tea | Experimental | Participants will be provided a confection containing green tea concentrate Receives: Dietary Supplement: Green Tea Concentrate |
| Control | Active comparator | Participants will be provided a confection devoid of green tea concentrate Receives: Dietary Supplement: Green Tea Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of Blood Glucose
Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.
Measured: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion
Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.
Measured: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Brachial Artery Flow-mediated Dilation
Measured: 0 min (baseline)
Brachial Artery Flow-mediated Dilation
Measured: 60 min
Secondary outcomes (4)
Malondialdehyde (0 Min)
Measured: Baseline (0 min)
Malondialdehyde
Measured: 60 min postprandially
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Measured: 0 min (baseline)
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Measured: 60 min (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2015
- Study completionApr 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Bruno, Ohio State University
- Investigators
- Richard Bruno, PhD, RD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857258
- Sponsor's protocol ID
- 2013H0116
- Status last verified
- Feb 2017
- First submitted
- 16 May 2013
- Last updated
- 16 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Sapper TN, Mah E, Ahn-Jarvis J, McDonald JD, Chitchumroonchokchai C, Reverri EJ, Vodovotz Y, Bruno RS. A green tea-containing starch confection increases plasma catechins without protecting against postprandial impairments in vascular function in normoglycemic adults. Food Funct. 2016 Sep 14;7(9):3843-53. doi: 10.1039/c6fo00639f. Epub 2016 Aug 5.
PubMed 27494176
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Confections For Managing Postprandial Hyperglycemia-Induced Vascular Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT01857258
- Acronym / sponsor ID
- 2013H0116
- Conditions
- Hyperglycemia, Cardiovascular Disease
- Keywords
- green tea, catechins, vascular endothelial function, postprandial hyperglycemia, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Posted 16 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to formulate and validate a green tea confection (i.e. "gummy" candy) as a strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by developing a green tea-containing confection, examining its physiochemical properties and its inhibition of starch digestion, and then validating its vasoprotective activities in healthy humans by assessing its blood glucose-regulating activities.
Detailed description
The study involves validating a green tea confection (i.e. "gummy" candy) as a dietary strategy to attenuate postprandial hyperglycemia-induced impairments in vascular function. The central hypothesis is that a green tea confection will protect against vascular endothelial dysfunction by suppressing postprandial hyperglycemia. The central hypothesis of this application will be assessed by providing research participants 75 grams of carbohydrate in the form of a confection that contains no green tea concentrate or green tea concentrate at a level equivalent to approximately 3 cups of freshly brewed tea. Blood glucose and brachial artery flow-mediated dilation will be assessed at regular intervals during the 3 hour postprandial period to define the extent to which green tea attenuates postprandial increases in blood glucose and decreases in vascular function that otherwise occur in a hyperglycemia-dependent manner.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Green Tea | Experimental | Dietary Supplement: Green Tea ConcentrateParticipants will be provided a confection containing green tea concentrate |
| Control | Active comparator | Dietary Supplement: Green Tea ConcentrateParticipants will be provided a confection devoid of green tea concentrate |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Plasma glucose <100 mg/dL
- Plasma total cholesterol <200 mg/dL
- Plasma triglycerides <140 mg/dL
- Blood pressure <140/90
- non-dietary supplement user for >2 months
Key exclusion criteria (3 listed)
- allergies or aversions to green tea and/or corn starch,
- excessive alcohol consumption (>3 drinks/d),
- >5 h/wk of aerobic activity
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 |
|---|---|---|
| Green Tea ConcentrateGreen tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose | Dietary supplement | Control, Green Tea |
Primary outcome
Area Under the Curve of Blood Glucose
Time frame: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.
Area Under the Curve of Brachial Artery Flow Mediated Dilatiion
Time frame: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose
Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.
Brachial Artery Flow-mediated Dilation
Time frame: 0 min (baseline)
Brachial Artery Flow-mediated Dilation
Time frame: 60 min
4 secondary outcomes
Malondialdehyde (0 Min)
Time frame: Baseline (0 min)
Malondialdehyde
Time frame: 60 min postprandially
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Time frame: 0 min (baseline)
Ratio of Asymmetric Dimethylarginine Relative to Arginine
Time frame: 60 min (baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27494176Sapper TN, Mah E, Ahn-Jarvis J, McDonald JD, Chitchumroonchokchai C, Reverri EJ, Vodovotz Y, Bruno RS. A green tea-containing starch confection increases plasma catechins without protecting against postprandial impairments in vascular function in normoglycemic adults. Food Funct. 2016 Sep 14;7(9):3843-53. doi: 10.1039/c6fo00639f. Epub 2016 Aug 5.
- Individual participant dataSharing planned: Yes
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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.
Richard Bruno, PhD, RD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Tea Concentrate in people with Hyperglycemia and Cardiovascular Disease, run by Ohio State University at 1 site in United States.
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 8 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 16 Feb 2017. 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 United States. 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. 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 16 Feb 2017). 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?
Area Under the Curve of Blood Glucose (time frame: Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01857258, which also lists 1 linked publication.
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 16 Feb 2017.