- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721643
Absorption Kinetics of Polyphenols in Angel's Plant (Angelica Keiskei)
April 24, 2017 updated by: Tufts University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- consume >7 alcoholic drinks/wk
- taking cholesterol medication or hormone replacement
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Healthy control, 5g dry power of angel's plant (Angelica keiskei)
|
Healthy control, one time dose of 5g dry power of Angelica keiskei
|
EXPERIMENTAL: 2
Metabolic syndrome, 5g dry powder of angel's plant (Angelica keiskei)
|
Metaboic syndrome subjects, one time dose of 5g dry powder of angel's plant (Angelica keiskei)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma quercetin
Time Frame: 0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min
|
0, 30, 60, 100, 180, 240, 300, 360, 420 & 480 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ACTUAL)
March 1, 2009
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
July 22, 2008
First Submitted That Met QC Criteria
July 23, 2008
First Posted (ESTIMATE)
July 24, 2008
Study Record Updates
Last Update Posted (ACTUAL)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HNRCA2580
- BioGreen 20070301034009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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