Clinical Trials Directory

Trials / Completed

CompletedNCT02562274

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Khon Kaen University · Academic / Other
Sex
Female
Age
45 Years – 60 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPlaceboSubjects are received placebo treatments once daily for 8 weeks
DIETARY_SUPPLEMENTMP 50 mg/daySubjects are received MP 50 mg/day treatments once daily for 8 weeks
DIETARY_SUPPLEMENTMP 1500 mg/daySubjects are received MP 1500 mg/day treatments once daily for 8 weeks

Timeline

Start date
2014-09-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2015-09-29
Last updated
2016-03-01

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT02562274. Inclusion in this directory is not an endorsement.