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

NCT02562274 | Completed Phase 1 DMC

• 1 other identifier: HE 571373
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Menopause; Cognitive impairment; Working memory; Bone formation markers; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Attention (N100) and cognitive processing (P300) determine by using Event Related Potential (Auditory oddball paradigm).

  3 months

Secondary Outcomes (5)

• Accuracy and time response of working memory by using computerized batteries test (CDR)

  3 months

• Bone formation marker by using serum calcium, serum alkaline phosphatase and serum osteocalcin

  2 months

• Acetylcholinesterase and monoamine oxidase type A ,B activities in serum

  2 months

• Psychological symptom by using SCL-90 questionnaire

  3 months

• Consumption safety of MP product by using the electrocardiogram (ECG), hematology, blood chemistry and blood pressure measurement.

  3 months

Study Arms (3)

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

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

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

Dietary Supplement: MP 1500 mg/day

Interventions

Placebo DIETARY_SUPPLEMENT

Subjects are received placebo treatments once daily for 8 weeks

Placebo group

MP 50 mg/day DIETARY_SUPPLEMENT

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

MP 50 mg/day

MP 1500 mg/day DIETARY_SUPPLEMENT

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

MP 1500 mg/day

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Jitanaporn Wattanathorn

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Osteoporosis

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jintanaporn Wattanathorn, Ph.D.

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 29, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

TH (1)