Evaluation of Consumption Safety and Effect of Mulberry Leaves and Vietnamese Coriander Based Instant Polyherbal Porridge on Working Memory and Bone Formation Markers

February 27, 2016 updated by: Jintanaporn Wattanathorn, Khon Kaen University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Jitanaporn Wattanathorn

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo group
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
Dietary supplement: Placebo
Subjects are received placebo treatments once daily for 8 weeks
Active Comparator: MP 50 mg/day
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
Dietary supplement: MP 50 mg/day
Subjects are received MP 50 mg/day treatments once daily for 8 weeks
Active Comparator: MP 1500 mg/day
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
Dietary supplement: MP 1500 mg/day
Subjects are received MP 1500 mg/day treatments once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Accuracy and time response of working memory by using computerized batteries test (CDR)
Time Frame: 3 months
3 months
Bone formation marker by using serum calcium, serum alkaline phosphatase and serum osteocalcin
Time Frame: 2 months
2 months
Acetylcholinesterase and monoamine oxidase type A ,B activities in serum
Time Frame: 2 months
2 months
Psychological symptom by using SCL-90 questionnaire
Time Frame: 3 months
3 months
Consumption safety of MP product by using the electrocardiogram (ECG), hematology, blood chemistry and blood pressure measurement.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Khon Kaen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jintanaporn Wattanathorn, Ph.D., Khon Kaen University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HE 571373

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