Oxidative StressNCT01278589
Antioxidative Effect of Plantago Asiatica L. Extract
A study testing Plantago asiatica L. extract 5g, Plantago asiatica L. extract 10g and Plantago asiatica L. extract 20g in people with Oxidative Stress, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Plantago asiatica L. extract 5g, Plantago asiatica L. extract 10g and Plantago asiatica L. extract 20g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Sep 2011
- Phase
- Interventional
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age over 30
- BMI(Body mass index) between 25 and 33 kg/m2
- Total cholesterol between 200mg/dL and 250mg/dL OR Triglyceride between 150mg/dL and 220mg/dL OR LDL-cholesterol between 130mg/dL and 165mg/dL
Who cannot join
- Subject who has taken part in other clinical trials within 30 days of screening visit
- Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect antioxidative biomarkers within 30days of screening visit
- Subject who is pregnant or breast feeding
- Subject who lost body weight over 4kg within 30days of screening visit
- Alcoholic
- Smoker
Show all 9Show fewer
- Subject who takes excessive exercise (over 7hours/week)
- Subject who has hypertension(≥140/90mmHg), diabetes(fasting blood glucose ≥126mg/dL), kidney disease, hepatic disease or hyperthyroidism within 2years
- Subject who has an allergy to the ingredients of study product
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ewha Womans University / Hanaro Medical Foundation
Seoul
About this study
Official title: Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study
The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia.
Read the detailed description
The purpose of this study is to evaluate an acute effect of Plantago asiatica L. extract consumption on antioxidative biomarkers in subjects with mild hyperlipidemia. Subjects will intake Plantago asiatica L. extract with a high fat meal for oxidative stress loading. Antioxidative biomarkers will be measured after single-dose administration of Plantago asiatica L. extract.
- Conditions
- Oxidative Stress
- Being tested
- Plantago asiatica L. extract 5g, Plantago asiatica L. extract 10g, Plantago asiatica L. extract 20g, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plantago asiatica L. extract 5gDietary supplement
Liquid (80g) containing Plantago asiatica L. extract 5g
Plantago asiatica L. extract 10gDietary supplement
Liquid (80g) containing Plantago asiatica L. extract 10g
Plantago asiatica L. extract 20gDietary supplement
Liquid (80g) containing Plantago asiatica L. extract 20g
PlaceboDietary supplement
Liquid (80g) without Plantago asiatica L. extract
| Study group | Role | What they receive |
|---|---|---|
| • Plantago asiatica L. extract 5g | Experimental | Not described Receives: Dietary Supplement: Plantago asiatica L. extract 5g |
| Plantago asiatica L. extract 10g | Experimental | Not described Receives: Dietary Supplement: Plantago asiatica L. extract 10g |
| Plantago asiatica L. extract 20g | Experimental | Not described Receives: Dietary Supplement: Plantago asiatica L. extract 20g |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comet assay after single-dose consumption of Plantago asiatica L. extract
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Secondary outcomes (6)
Plasma FRAP
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma MDA
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma FFA
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma ox-LDL
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma erythrocyte SOD
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma triglyceride
Measured: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
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 startDec 2010
- Primary completionApr 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry for Food, Agriculture, Forestry and Fisheries, Korea
- Responsible party
- Principal investigator, Oran Kwon, Ewha Womans University
- Investigators
- Oran Kwon, Ph.D, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278589
- Sponsor's protocol ID
- PLA_Biofood
- Status last verified
- Oct 2011
- First submitted
- 18 Jan 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sun Y. Free radicals, antioxidant enzymes, and carcinogenesis. Free Radic Biol Med. 1990;8(6):583-99. doi: 10.1016/0891-5849(90)90156-d.
PubMed 2193855Liu X, Wu X, Huang H, Zhong S, Lai X, Cao L. [Herbalogical study on Plantago asiatica L]. Zhong Yao Cai. 2002 Jan;25(1):46-8. Chinese.
PubMed 12583244Choi SY, Jung SH, Lee HS, Park KW, Yun BS, Lee KW. Glycation inhibitory activity and the identification of an active compound in Plantago asiatica extract. Phytother Res. 2008 Mar;22(3):323-9. doi: 10.1002/ptr.2316.
PubMed 18167045Chung MJ, Park KW, Kim KH, Kim CT, Baek JP, Bang KH, Choi YM, Lee SJ. Asian plantain (Plantago asiatica) essential oils suppress 3-hydroxy-3-methyl-glutaryl-co-enzyme A reductase expression in vitro and in vivo and show hypocholesterolaemic properties in mice. Br J Nutr. 2008 Jan;99(1):67-75. doi: 10.1017/S0007114507798926. Epub 2007 Aug 15.
PubMed 17697428Xu C, Luo L, Tan RX. Antidepressant effect of three traditional Chinese medicines in the learned helplessness model. J Ethnopharmacol. 2004 Apr;91(2-3):345-9. doi: 10.1016/j.jep.2004.01.012.
PubMed 15120459Lee SJ. Korean folk medicine. Publishing center of Seoul National Unicersity, Seoul. P 130, 1966
Jeong CH, Bae YI, Shim KH, Choi JS. DPPH radical scavenging effect and antimicrobial activities of Plantain (Plantago asiatica L.) extracts. J Korean Soc Food Sci Nutr 33(10): 1601-1605, 2004
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study
- ClinicalTrials.gov ID
- NCT01278589
- Acronym / sponsor ID
- PLA_Biofood
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Collaborators
- Ministry for Food, Agriculture, Forestry and Fisheries, Korea
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Jan 2011 (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 purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia.
Detailed description
The purpose of this study is to evaluate an acute effect of Plantago asiatica L. extract consumption on antioxidative biomarkers in subjects with mild hyperlipidemia. Subjects will intake Plantago asiatica L. extract with a high fat meal for oxidative stress loading. Antioxidative biomarkers will be measured after single-dose administration of Plantago asiatica L. extract.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| • Plantago asiatica L. extract 5g | Experimental | Dietary Supplement: Plantago asiatica L. extract 5g |
| Plantago asiatica L. extract 10g | Experimental | Dietary Supplement: Plantago asiatica L. extract 10g |
| Plantago asiatica L. extract 20g | Experimental | Dietary Supplement: Plantago asiatica L. extract 20g |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age over 30
- BMI(Body mass index) between 25 and 33 kg/m2
- Total cholesterol between 200mg/dL and 250mg/dL OR Triglyceride between 150mg/dL and 220mg/dL OR LDL-cholesterol between 130mg/dL and 165mg/dL
Key exclusion criteria (9 listed)
- Subject who has taken part in other clinical trials within 30 days of screening visit
- Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect antioxidative biomarkers within 30days of screening visit
- Subject who is pregnant or breast feeding
- Subject who lost body weight over 4kg within 30days of screening visit
- Alcoholic
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 |
|---|---|---|
| Plantago asiatica L. extract 5gLiquid (80g) containing Plantago asiatica L. extract 5g | Dietary supplement | • Plantago asiatica L. extract 5g |
| Plantago asiatica L. extract 10gLiquid (80g) containing Plantago asiatica L. extract 10g | Dietary supplement | Plantago asiatica L. extract 10g |
| Plantago asiatica L. extract 20gLiquid (80g) containing Plantago asiatica L. extract 20g | Dietary supplement | Plantago asiatica L. extract 20g |
| PlaceboLiquid (80g) without Plantago asiatica L. extract | Dietary supplement | Placebo |
Primary outcome
Comet assay after single-dose consumption of Plantago asiatica L. extract
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
6 secondary outcomes
Plasma FRAP
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma MDA
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma FFA
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma ox-LDL
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma erythrocyte SOD
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
Plasma triglyceride
Time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
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 28 Oct 2011.
- Background: PubMed 2193855Sun Y. Free radicals, antioxidant enzymes, and carcinogenesis. Free Radic Biol Med. 1990;8(6):583-99. doi: 10.1016/0891-5849(90)90156-d.
- Background: PubMed 12583244Liu X, Wu X, Huang H, Zhong S, Lai X, Cao L. [Herbalogical study on Plantago asiatica L]. Zhong Yao Cai. 2002 Jan;25(1):46-8. Chinese.
- Background: PubMed 18167045Choi SY, Jung SH, Lee HS, Park KW, Yun BS, Lee KW. Glycation inhibitory activity and the identification of an active compound in Plantago asiatica extract. Phytother Res. 2008 Mar;22(3):323-9. doi: 10.1002/ptr.2316.
- Background: PubMed 17697428Chung MJ, Park KW, Kim KH, Kim CT, Baek JP, Bang KH, Choi YM, Lee SJ. Asian plantain (Plantago asiatica) essential oils suppress 3-hydroxy-3-methyl-glutaryl-co-enzyme A reductase expression in vitro and in vivo and show hypocholesterolaemic properties in mice. Br J Nutr. 2008 Jan;99(1):67-75. doi: 10.1017/S0007114507798926. Epub 2007 Aug 15.
- Background: PubMed 15120459Xu C, Luo L, Tan RX. Antidepressant effect of three traditional Chinese medicines in the learned helplessness model. J Ethnopharmacol. 2004 Apr;91(2-3):345-9. doi: 10.1016/j.jep.2004.01.012.
- BackgroundLee SJ. Korean folk medicine. Publishing center of Seoul National Unicersity, Seoul. P 130, 1966
- BackgroundJeong CH, Bae YI, Shim KH, Choi JS. DPPH radical scavenging effect and antimicrobial activities of Plantain (Plantago asiatica L.) extracts. J Korean Soc Food Sci Nutr 33(10): 1601-1605, 2004
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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.
Oran Kwon, Ph.D principal investigator
Ewha Womans 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 Plantago asiatica L. extract 5g, Plantago asiatica L. extract 10g and Plantago asiatica L. extract 20g in people with Oxidative Stress, run by Ewha Womans University at 1 site in South Korea.
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 9 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 28 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 South Korea. 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?
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?
Comet assay after single-dose consumption of Plantago asiatica L. extract (time frame: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)). 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 NCT01278589, which also lists 7 linked publications.
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 28 Oct 2011.