Cardiovascular HealthPhase 1NCT01162213
Pilot Study of Lychee Fruit Extract to Promote Cardiovascular Health
A Phase 1 study testing Lychee Fruit Extract in people with Cardiovascular Health, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators hypothesize that acute and short term consumption of a lychee fruit extract, particularly rich in low molecular weight dietary flavanols, will improve vascular function and reduce platelet reactivity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Lychee Fruit Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2010
- Phase
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female Age 52 to 65 yrs.
- Male Age 18 to 35 yrs.
- Female and male >110 pounds
- Lack of menses in the last year and FSH 23-116.3 mIU/mL
- Subject is willing and able to comply with the study protocols.
- Subject is willing to consume the lychee fruit extract or placebo capsule twice a day.
- BMI 20-35 kg/m2
Who cannot join
- Physical signs of health impairment
- Weight < 110 pounds
- BMI >35 kg/m2
- Blood Pressure > 140/90 mm Hg
- Diabetes
- Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
Show all 26Show fewer
- Abnormal clinical laboratory test (CBC, comprehensive metabolic panel, etc.) if determined to be clinically significant by Dr. M. Eric Gershwin.
- PFA-100 readings 10% outside of normal reference range (normal reference range for ADP-Collagen cartridge: 71-118 sec; Epinephrine-Collagen cartridge: 94-193 sec).
- Inflammatory disorders (e.g. rheumatoid arthritis)
- Malabsorption
- Treatment with corticosteroids, hypolipidemic and anti-inflammatory drugs
- Renal or liver disease
- History of cancer
- Heart disease, which includes cardiovascular events and Stroke
- Cushing's syndrome
- History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.
- Anxiety medications
- Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids
- Asthma (can be worsened by mild to moderate food allergies)
- Indications of substance or alcohol abuse within the last 3 years
- Multi-vitamin and mineral use other than a general formula, once per day tablet
- Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and unwilling to discontinue use while participating in the study
- Alcohol consumption > 1 oz/day (2 beers/day or 2 glasses of wine/ day, 1 drink of hard liquor/day)
- Allergies to fruit
- Chronic/routine high-intensity exercise
- Smoking or actively in smoking cessation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Effects of Lychee Fruit Extract on Vascular Function and Inflammation in Postmenopausal Women: a Double-Blind, Crossover Study
The investigators hypothesize that acute and short term consumption of a lychee fruit extract, particularly rich in low molecular weight dietary flavanols, will improve vascular function and reduce platelet reactivity.
Read the detailed description
Several large-scale epidemiologic studies have indicated that chronic consumption of flavonoid-rich foods appear to be associated with decreased risk for several chronic diseases including cancer, diabetes, cardiovascular disease, and stroke. In humans, consumption of several flavonoid-rich foods and beverages, such as berries, teas, cocoa, and grapes have been reported to improve vascular endothelial function and decrease platelet reactivity. Previous work at UC Davis by Dr. Keen and colleagues has helped define the role of flavanols in vascular function, and has used a flavanol-rich cocoa extract as the test material. In this proposed study, we seek to explore the role of a lychee fruit extract rich in flavanols, and its effects of vascular and metabolic parameters.
- Conditions
- Cardiovascular Health
- Being tested
- Lychee Fruit Extract
- Keywords
- Postmenopausal Women, Healthy Males, Cardiovascular, Flavanols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lychee Fruit ExtractDietary supplement
placebo or 100, 200 and 600 mg of lychee fruit extract for 2 weeks with one week washout period between treatments 2000 mg of lychee fruit extract given at a single visit
| Study group | Role | What they receive |
|---|---|---|
| 100 mg of Lychee fruit extract | Experimental | Not described Receives: Dietary Supplement: Lychee Fruit Extract |
| 200 mg of Lychee fruit extract | Experimental | Not described Receives: Dietary Supplement: Lychee Fruit Extract |
| 600 mg of Lychee fruit extract | Experimental | Not described Receives: Dietary Supplement: Lychee Fruit Extract |
| 2000 mg of Lychee fruit extract | Experimental | Not described Receives: Dietary Supplement: Lychee Fruit Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Arterial Tonometry
Measured: 0, 2 and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Robert M Hackman, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162213
- Sponsor's protocol ID
- 200916915-2
- Status last verified
- Aug 2010
- First submitted
- 12 Jul 2010
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lychee Fruit Extract on Vascular Function and Inflammation in Postmenopausal Women: a Double-Blind, Crossover Study
- ClinicalTrials.gov ID
- NCT01162213
- Acronym / sponsor ID
- 200916915-2
- Conditions
- Cardiovascular Health
- Keywords
- Postmenopausal Women, Healthy Males, Cardiovascular, Flavanols
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Jul 2010 (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 investigators hypothesize that acute and short term consumption of a lychee fruit extract, particularly rich in low molecular weight dietary flavanols, will improve vascular function and reduce platelet reactivity.
Detailed description
Several large-scale epidemiologic studies have indicated that chronic consumption of flavonoid-rich foods appear to be associated with decreased risk for several chronic diseases including cancer, diabetes, cardiovascular disease, and stroke. In humans, consumption of several flavonoid-rich foods and beverages, such as berries, teas, cocoa, and grapes have been reported to improve vascular endothelial function and decrease platelet reactivity. Previous work at UC Davis by Dr. Keen and colleagues has helped define the role of flavanols in vascular function, and has used a flavanol-rich cocoa extract as the test material. In this proposed study, we seek to explore the role of a lychee fruit extract rich in flavanols, and its effects of vascular and metabolic parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100 mg of Lychee fruit extract | Experimental | Dietary Supplement: Lychee Fruit Extract |
| 200 mg of Lychee fruit extract | Experimental | Dietary Supplement: Lychee Fruit Extract |
| 600 mg of Lychee fruit extract | Experimental | Dietary Supplement: Lychee Fruit Extract |
| 2000 mg of Lychee fruit extract | Experimental | Dietary Supplement: Lychee Fruit Extract |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female Age 52 to 65 yrs.
- Male Age 18 to 35 yrs.
- Female and male >110 pounds
- Lack of menses in the last year and FSH 23-116.3 mIU/mL
- Subject is willing and able to comply with the study protocols.
Key exclusion criteria (26 listed)
- Physical signs of health impairment
- Weight < 110 pounds
- BMI >35 kg/m2
- Blood Pressure > 140/90 mm Hg
- Diabetes
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 |
|---|---|---|
| Lychee Fruit Extractplacebo or 100, 200 and 600 mg of lychee fruit extract for 2 weeks with one week washout period between treatments 2000 mg of lychee fruit extract given at a single visit | Dietary supplement | 100 mg of Lychee fruit extract, 200 mg of Lychee fruit extract, 2000 mg of Lychee fruit extract, 600 mg of Lychee fruit extract |
Primary outcome
Peripheral Arterial Tonometry
Time frame: 0, 2 and 4 hours
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 23 Aug 2010.
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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.
Robert M Hackman, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lychee Fruit Extract in people with Cardiovascular Health, run by University of California, Davis 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 7 inclusion and 26 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 23 Aug 2010. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Peripheral Arterial Tonometry (time frame: 0, 2 and 4 hours). 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 23 Aug 2010.