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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562274
• Other study ID #: HE 571373
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2015
• Last updated: February 27, 2016
• Start date: September 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical 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. Forty-five participants were randomly assigned to receive a placebo or MP (50, 1500 mg) treatments once daily for 8 weeks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Placebo
Subjects are received placebo treatments once daily for 8 weeks
• MP 50 mg/day
Subjects are received MP 50 mg/day treatments once daily for 8 weeks
• MP 1500 mg/day
Subjects are received MP 1500 mg/day treatments once daily for 8 weeks

Locations

Country	Name	City	State
Thailand	Jitanaporn Wattanathorn	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).		3 months	No
Secondary	Accuracy and time response of working memory by using computerized batteries test (CDR)		3 months	No
Secondary	Bone formation marker by using serum calcium, serum alkaline phosphatase and serum osteocalcin		2 months	No
Secondary	Acetylcholinesterase and monoamine oxidase type A ,B activities in serum		2 months	No
Secondary	Psychological symptom by using SCL-90 questionnaire		3 months	No
Secondary	Consumption safety of MP product by using the electrocardiogram (ECG), hematology, blood chemistry and blood pressure measurement.		3 months	Yes