Oxidative StressEarly Phase 1NCT00721643
Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)
A Early Phase 1 study testing angel's plant (Angelica keiskei) in people with Oxidative Stress, run by Tufts University at 1 site in United States.
Trial summary
The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in this pilot study. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- angel's plant (Angelica keiskei)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects (>60 yr, n=5)
- subjects with metabolic syndrome (>60 yr, n=5)
- Subjects who has
- high fasting plasma glucose (>5.6 mmol/L),
- central obesity (waist-hip ratio, >0.9 for men, >0.85 for women)
- either high blood pressure (>130/85 mmHg) or high triacylglycerol (>1.7 mmol/L) will be selected to have metabolic syndrome.
- normal hematological parameters, normal serum albumin, normal liver function, and normal kidney function
- no history of smoking or alcoholism.
Who cannot join
- consume >7 alcoholic drinks/wk
- taking cholesterol medication or hormone replacement
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in this pilot study.
- Conditions
- Oxidative Stress
- Being tested
- angel's plant (Angelica keiskei)
- Keywords
- Angelica keiskei, absorption kinetics, quercetin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angel's plant (Angelica keiskei)Dietary supplement
Healthy control, one time dose of 5g dry power of Angelica keiskei
Angel's plant (Angelica keiskei)Dietary supplement
Metaboic syndrome subjects, one time dose of 5g dry powder of angel's plant (Angelica keiskei)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Healthy control, 5g dry power of angel's plant (Angelica keiskei) Receives: Dietary Supplement: angel's plant (Angelica keiskei) |
| 2 | Experimental | Metabolic syndrome, 5g dry powder of angel's plant (Angelica keiskei) Receives: Dietary Supplement: Angel's plant (Angelica keiskei) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma quercetin
Measured: 0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Jin Yeum, Ph.D., Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721643
- Sponsor's protocol ID
- HNRCA2580
- Other IDs
- BioGreen 20070301034009
- Status last verified
- Apr 2017
- First submitted
- 22 Jul 2008
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)
- ClinicalTrials.gov ID
- NCT00721643
- Acronym / sponsor ID
- HNRCA2580
- Conditions
- Oxidative Stress
- Keywords
- Angelica keiskei, absorption kinetics, quercetin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The absorption kinetics of polyphenols in angel's plant (Angelica keiskei), which is a dark green leafy vegetable rich in antioxidant nutrients, will be determined in older adults in this pilot study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: angel's plant (Angelica keiskei)Healthy control, 5g dry power of angel's plant (Angelica keiskei) |
| 2 | Experimental | Dietary Supplement: Angel's plant (Angelica keiskei)Metabolic syndrome, 5g dry powder of angel's plant (Angelica keiskei) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy subjects (>60 yr, n=5)
- subjects with metabolic syndrome (>60 yr, n=5)
- Subjects who has
- normal hematological parameters, normal serum albumin, normal liver function, and normal kidney function
- no history of smoking or alcoholism.
Key exclusion criteria (2 listed)
- consume >7 alcoholic drinks/wk
- taking cholesterol medication or hormone replacement
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 |
|---|---|---|
| angel's plant (Angelica keiskei)Healthy control, one time dose of 5g dry power of Angelica keiskei | Dietary supplement | 1 |
| Angel's plant (Angelica keiskei)Metaboic syndrome subjects, one time dose of 5g dry powder of angel's plant (Angelica keiskei) | Dietary supplement | 2 |
Primary outcome
Plasma quercetin
Time frame: 0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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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.
Kyung-Jin Yeum, Ph.D. principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing angel's plant (Angelica keiskei) in people with Oxidative Stress, run by Tufts 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 2 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 25 Apr 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma quercetin (time frame: 0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min). 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 25 Apr 2017.