HealthyPhase 1NCT02567760
Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
A Phase 1 study testing MP1 in people with Healthy, run by Khon Kaen University.
Trial summary
This study is set up to determine the cognitive enhancing effect and consumption safety of the novel cognitive enhancement product made from the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MP1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2016
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy perimenopausal and postmenopausal women (<5 years menstruation cessation) who live in Northeastern of Thailand.
Who cannot join
- Subject who is diagnosed with one of the following: cardiovascular diseases, respiratory diseases,neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
- Hysterectomy and/or Oophorectomy
- Subject who use hormone or any drug exerts the influence on Hypothalamic Pituitary Gonadal axis and nervous system.
- Body mass index >27
- Athlete or subject who has a regular exercise.
- Smoker or heavy drinker
About this study
This study is set up to determine the cognitive enhancing effect and consumption safety of the novel cognitive enhancement product made from the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.
Read the detailed description
Memory impairment is one of the common health problems in menopausal women. Due to the therapeutic efficiency limitation, the searching for the protective intervention for this condition is required. Based on the previous findings that the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) could attenuate memory impairment in animal model of menopause, the investigators aimed to investigate the effect of MP1 functional drink on working memory, psychological fitness, possible underlying mechanism and the consumption safety in menopausal volunteers.
- Conditions
- Healthy
- Being tested
- MP1, Placebo
- Keywords
- MP1, cognitive enhancing effect, menopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP1Dietary supplement
Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.
PlaceboOther
Subjects receive Placebo drink after meal for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MP1 group | Active comparator | Subjects receive the MP1 product at the dose of 400 mg/day for 8 weeks. Receives: Dietary Supplement: MP1 |
| Placebo group | Placebo comparator | Subject receive the Placebo product for 8 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive processing (P300) and attention (N100) using Event Related Potential
Measured: 7 months
Secondary outcomes (10)
Accuracy and speed of working memory using computerized battery test
Measured: 7 months
Psychological fitness using Bond-Ladder test and Symptom Check List-90 test (SCL-90)
Measured: 7 months
Malondialdehyde level in serum
Measured: 7 month
The activity of Superoxide dismutase enzyme in serum
The activity of Superoxide dismutase (SOD) enzyme in serum is measured by using the biochemical assay method and the activity of SOD is expressed as units/mg protein. The higher activity of SOD enzyme is the better antioxidant effect of the intervention.
Measured: 7 month
The activity of Glutathione Peroxidase enzyme in serum
The activity of Glutathione Peroxidase (GSH-Px) enzyme in serum is measured by using the biochemical assay method and the activity of GSH-Px is expressed as units/mg protein. The higher activity of GSH-Px enzyme is the better antioxidant effect of the intervention.
Measured: 7 month
The activity of Catalase enzyme in serum
The activity of Catalase enzyme in serum is measured by using the biochemical assay method and the activity of CAT is expressed as units/mg protein. The higher activity of CAT enzyme is the better antioxidant effect of the intervention.
Measured: 7 month
The activity of Acetylcholinesterase enzyme in serum
Acetylcholinesterase (AChE) is an enzyme that catalyzes the breakdown of Acetylcholine, a neurotransmitter for learning and memory.The activity of AChE enzyme in serum is measured by using the biochemical assay method and the result is express as mmol/min.g protein. The lower activity of AChE is the better cognitive enhancing effect of the intervention.
Measured: 7 month
The activity of Monoamine oxidase enzyme in serum
Monoamine oxidase (MAO) is an enzyme that catalyzes the breakdown of Monoamine neurotransmitter , a neurotransmitter for learning and memory.The activity of MAO enzyme in serum is measured by using the biochemical assay method and the result is express as nmol/h/mg protein. The lower activity of MAO is the better cognitive enhancing effect of the intervention.
Measured: 7 month
Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement
Measured: 7 months
Adverse events by using adverse event record form
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jintanaporn Wattanathorn, Khon Kaen University
- Investigators
- Jintanaporn Wattanathorn, PhD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567760
- Sponsor's protocol ID
- HE 571329
- Status last verified
- Feb 2016
- First submitted
- 18 Sep 2015
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
- ClinicalTrials.gov ID
- NCT02567760
- Acronym / sponsor ID
- HE 571329
- Conditions
- Healthy
- Keywords
- MP1, cognitive enhancing effect, menopausal women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Oct 2015 (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.
This study is set up to determine the cognitive enhancing effect and consumption safety of the novel cognitive enhancement product made from the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.
Detailed description
Memory impairment is one of the common health problems in menopausal women. Due to the therapeutic efficiency limitation, the searching for the protective intervention for this condition is required. Based on the previous findings that the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) could attenuate memory impairment in animal model of menopause, the investigators aimed to investigate the effect of MP1 functional drink on working memory, psychological fitness, possible underlying mechanism and the consumption safety in menopausal volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP1 group | Active comparator | Dietary Supplement: MP1Subjects receive the MP1 product at the dose of 400 mg/day for 8 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboSubject receive the Placebo product for 8 weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy perimenopausal and postmenopausal women (<5 years menstruation cessation) who live in Northeastern of Thailand.
Key exclusion criteria (6 listed)
- Subject who is diagnosed with one of the following: cardiovascular diseases, respiratory diseases,neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
- Hysterectomy and/or Oophorectomy
- Subject who use hormone or any drug exerts the influence on Hypothalamic Pituitary Gonadal axis and nervous system.
- Body mass index >27
- Athlete or subject who has a regular exercise.
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 |
|---|---|---|
| MP1Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks. | Dietary supplement | MP1 group |
| PlaceboSubjects receive Placebo drink after meal for 8 weeks. | Other | Placebo group |
Primary outcome
Cognitive processing (P300) and attention (N100) using Event Related Potential
Time frame: 7 months
10 secondary outcomes
Accuracy and speed of working memory using computerized battery test
Time frame: 7 months
Psychological fitness using Bond-Ladder test and Symptom Check List-90 test (SCL-90)
Time frame: 7 months
Malondialdehyde level in serum
Time frame: 7 month
The activity of Superoxide dismutase enzyme in serum
Time frame: 7 month
The activity of Glutathione Peroxidase enzyme in serum
Time frame: 7 month
The activity of Catalase enzyme in serum
Time frame: 7 month
The activity of Acetylcholinesterase enzyme in serum
Time frame: 7 month
The activity of Monoamine oxidase enzyme in serum
Time frame: 7 month
Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement
Time frame: 7 months
Adverse events by using adverse event record form
Time frame: 7 months
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 1 Mar 2016.
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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.
Jintanaporn Wattanathorn, PhD principal investigator
Khon Kaen University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MP1 in people with Healthy, run by Khon Kaen University.
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 1 inclusion and 6 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Cognitive processing (P300) and attention (N100) using Event Related Potential (time frame: 7 months). 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 1 Mar 2016.