HealthyPhase 1NCT02562274
Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers
A Phase 1 study testing MP 50 mg/day and MP 1500 mg/day in people with Healthy, run by Khon Kaen University at 1 site in Thailand.
Trial summary
This study the investigators aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. 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?
- MP 50 mg/day and MP 1500 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2014to Nov 2015
- 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.
- Aged between 45-60 years old
- All volunteers don't have serious physical illness such as diabetes, high blood pressure, heart disease, liver disease, kidney disease, lung disease, allergies and mental disorder.
- All volunteers don't get medicine or hormone or other medicines that affect the nervous system and bone during the trial and within three months before the start of the test.
- All volunteers don't smoking more than 10 pieces/ day
- All volunteers don't have alcohol addiction
- On the day of the study, all volunteers felt well and refrain from drinking tea, coffee or alcohol at least 12 hour.
Who cannot join
- Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease, hematological disorder, and gout or high uric acid.
- Volunteers who exposed to pesticides during one week before the test.
- Volunteers who have been Hysterectomy and/or Oophorectomy
- Volunteers who use hormone or any drug that effect on Hypothalamic Pituitary Gonadal axis and nervous system.
- Volunteers who require supplements or any drug that effect on the nervous system by order of the doctor during trial.
- Alcohol addiction
Show all 10Show fewer
- Smoking addiction (smoking more than 10 pieces/ day)
- Athlete or volunteers who have a regular exercise more than 3 time/weeks
- Volunteers who don't follow instructions during the trial.
- Volunteers who participate in other projects.
Trial locations and contacts
1 site in 1 country.
About this study
This study the investigators aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.
Read the detailed description
At present, the novel cheap and effective intervention against menopause related symptoms such as memory impairment and osteoporosis is still required due to the increased breast cancer risk induced by hormone replacement therapy. Based on the role of oxidative stress on cognitive deficit in menopause and the synergistic effect of herbs in traditional folklore, the cognitive enhancing effects and anti-osteoporosis effects of the functional food containing the combined extract of herbs possessing antioxidant effect has gained attention. Therefore, we aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks. The cognitive function and working memory were assessed via the auditory oddball paradigm of event-related potentials and computerized battery tests respectively prior to the intervention, 1 month, 2 month, and at delay 1 month. Bone formation markers including serum calcium, alkaline phosphatase, and osteocalcin were determine prior to the intervention and at the end of study.
- Conditions
- Healthy
- Being tested
- Placebo, MP 50 mg/day, MP 1500 mg/day
- Keywords
- Menopause, Cognitive impairment, Working memory, Bone formation markers, Osteoporosis
- Medical subject headings
- Cognitive Dysfunction, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects are received placebo treatments once daily for 8 weeks
MP 50 mg/dayDietary supplement
Subjects are received MP 50 mg/day treatments once daily for 8 weeks
MP 1500 mg/dayDietary supplement
Subjects are received MP 1500 mg/day treatments once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Subjects are received the placebo product which has same color and smell look like the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) treatments once daily for 8 weeks Receives: Dietary Supplement: Placebo |
| MP 50 mg/day | Active comparator | Subjects are received the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) 50 mg/day treatments once daily for 8 weeks Receives: Dietary Supplement: MP 50 mg/day |
| MP 1500 mg/day | Active comparator | Subjects are received the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) 1500 mg/day treatments once daily for 8 weeks Receives: Dietary Supplement: MP 1500 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).
Measured: 3 months
Secondary outcomes (5)
Accuracy and time response of working memory by using computerized batteries test (CDR)
Measured: 3 months
Bone formation marker by using serum calcium, serum alkaline phosphatase and serum osteocalcin
Measured: 2 months
Acetylcholinesterase and monoamine oxidase type A ,B activities in serum
Measured: 2 months
Psychological symptom by using SCL-90 questionnaire
Measured: 3 months
Consumption safety of MP product by using the electrocardiogram (ECG), hematology, blood chemistry and blood pressure measurement.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionNov 2015
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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, Ph.D., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562274
- Sponsor's protocol ID
- HE 571373
- Status last verified
- Feb 2016
- First submitted
- 18 Sep 2015
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers
- ClinicalTrials.gov ID
- NCT02562274
- Acronym / sponsor ID
- HE 571373
- Conditions
- Healthy
- Keywords
- Menopause, Cognitive impairment, Working memory, Bone formation markers, Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Sep 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 the investigators aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.
Detailed description
At present, the novel cheap and effective intervention against menopause related symptoms such as memory impairment and osteoporosis is still required due to the increased breast cancer risk induced by hormone replacement therapy. Based on the role of oxidative stress on cognitive deficit in menopause and the synergistic effect of herbs in traditional folklore, the cognitive enhancing effects and anti-osteoporosis effects of the functional food containing the combined extract of herbs possessing antioxidant effect has gained attention. Therefore, we aimed to determine the effect of the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) on cognitive function and bone formation markers of menopausal women. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks. The cognitive function and working memory were assessed via the auditory oddball paradigm of event-related potentials and computerized battery tests respectively prior to the intervention, 1 month, 2 month, and at delay 1 month. Bone formation markers including serum calcium, alkaline phosphatase, and osteocalcin were determine prior to the intervention and at the end of study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboSubjects are received the placebo product which has same color and smell look like the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) treatments once daily for 8 weeks |
| MP 50 mg/day | Active comparator | Dietary Supplement: MP 50 mg/daySubjects are received the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) 50 mg/day treatments once daily for 8 weeks |
| MP 1500 mg/day | Active comparator | Dietary Supplement: MP 1500 mg/daySubjects are received the herbal porridge containing the combined extract of mulberry and Vietnamese coriander (MP) 1500 mg/day treatments once daily for 8 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy perimenopausal and postmenopausal women (<5 years menstruation cessation) who live in Northeastern of Thailand.
- Aged between 45-60 years old
- All volunteers don't have serious physical illness such as diabetes, high blood pressure, heart disease, liver disease, kidney disease, lung disease, allergies and mental disorder.
- All volunteers don't get medicine or hormone or other medicines that affect the nervous system and bone during the trial and within three months before the start of the test.
- All volunteers don't smoking more than 10 pieces/ day
Key exclusion criteria (10 listed)
- Volunteers who have been diagnosed with one of the following; cardiovascular diseases, respiratory diseases, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease, hematological disorder, and gout or high uric acid.
- Volunteers who exposed to pesticides during one week before the test.
- Volunteers who have been Hysterectomy and/or Oophorectomy
- Volunteers who use hormone or any drug that effect on Hypothalamic Pituitary Gonadal axis and nervous system.
- Volunteers who require supplements or any drug that effect on the nervous system by order of the doctor during trial.
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 |
|---|---|---|
| PlaceboSubjects are received placebo treatments once daily for 8 weeks | Dietary supplement | Placebo group |
| MP 50 mg/daySubjects are received MP 50 mg/day treatments once daily for 8 weeks | Dietary supplement | MP 50 mg/day |
| MP 1500 mg/daySubjects are received MP 1500 mg/day treatments once daily for 8 weeks | Dietary supplement | MP 1500 mg/day |
Primary outcome
Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).
Time frame: 3 months
5 secondary outcomes
Accuracy and time response of working memory by using computerized batteries test (CDR)
Time frame: 3 months
Bone formation marker by using serum calcium, serum alkaline phosphatase and serum osteocalcin
Time frame: 2 months
Acetylcholinesterase and monoamine oxidase type A ,B activities in serum
Time frame: 2 months
Psychological symptom by using SCL-90 questionnaire
Time frame: 3 months
Consumption safety of MP product by using the electrocardiogram (ECG), hematology, blood chemistry and blood pressure measurement.
Time frame: 3 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, Ph.D. principal investigator
Khon Kaen University
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 MP 50 mg/day and MP 1500 mg/day in people with Healthy, run by Khon Kaen University at 1 site in Thailand.
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 10 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.
Where is the study taking place?
The record lists 1 site in Thailand. 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.
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?
Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm). (time frame: 3 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; AzTrials last refreshed its copy on 8 Nov 2026.