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

NCT ID: NCT02562274

Last Updated: 2016-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-11-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Subjects are received placebo treatments once daily for 8 weeks

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

Group Type: ACTIVE_COMPARATOR

MP 50 mg/day

Intervention Type: DIETARY_SUPPLEMENT

Subjects are received MP 50 mg/day treatments once daily for 8 weeks

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

Group Type: ACTIVE_COMPARATOR

MP 1500 mg/day

Intervention Type: DIETARY_SUPPLEMENT

Subjects are received MP 1500 mg/day treatments once daily for 8 weeks

Interventions

Placebo

Subjects are received placebo treatments once daily for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

MP 50 mg/day

Subjects are received MP 50 mg/day treatments once daily for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

MP 1500 mg/day

Subjects are received MP 1500 mg/day treatments once daily for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Jintanaporn Wattanathorn

Associate Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jintanaporn Wattanathorn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Jitanaporn Wattanathorn

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

Other Identifiers

HE 571373

Identifier Type: -

Identifier Source: org_study_id