Effects of Deer Bone Extract NS on Improvement in Cognitive-Bio-Markers of Cognitive Functions

Not Applicable

Completed

• Conditions: Healthy Adults With Subjective Memory Complaints
• Interventions: Dietary Supplement: NS 1100mg; Dietary Supplement: placebo; Dietary Supplement: NS 550mg

• Registration Number: NCT02379481
• Lead Sponsor: Ewha Womans University

Brief Summary

This study aims to elucidate the effects of deer bone extract NS on cognitive function improvement and its safety in healthy adults aged 40 to 65 years who report decline in subjective cognitive functions using multimodal neuroimaging and neurocognitive assessments.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Age between 40 and 65 years old,
• Global Deterioration Scale score (GDS) of 2
• High school or higher levels of education.

Exclusion Criteria

• Current pregnancy or breast-feeding
• Evidence of neurologic or medical conditions
• Axis I diagnosis when assessed by the board certified psychiatrist using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV)(SCID-IV),
• One or more major depressive episode during last 12 months
• Mini-mental status examination score of 24 or less
• Clinical Dementia Rating score of 0.5 or more suggesting cognitive impairment beyond self-perceived subjective deficits
• Intelligence quotient less than 70
• Any history of head trauma involving loss of consciousness or seizure
• Contraindications to magnetic resonance imaging (MRI)
• Use of psychotropics in last 3 months
• Use of oral contraceptive medication
• Participation in other clinical trials during the study period that might affect the outcome of the present study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NS 1100mg	NS 1100mg	NS 1100mg/day
placebo	placebo	placebo
NS 550mg	NS 550mg	NS 550mg/day

Primary Outcome Measures

Name	Time	Method
Changes from baseline in neurocognitive function	Baseline, 8th week	Scores from neurocognitive test batteries such as CANTAB
Changes from baseline in brain structure analyzed using the computational approach	Baseline, 8th week	Morphometric analysis of brain structures in magnetic resonance imaging
Changes from baseline in brain function analyzed using the computational approach	Baseline, 8th week	Blood oxygenation level dependent (BOLD) signal intensity and their connectivity assessed using functional magnetic resonance imaging scans
Changes from baseline in brain biochemical metabolism analyzed using the computational approach	Baseline, 8th week	Brain metabolite concentrations assessed using magnetic resonance spectroscopy

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Subjective Memory Complaints Questionnaire scores at 8th weeks	Baseline, 8th week
Number of participants with adverse events	8th week

Trial Locations

Locations (1)

Ewha Womans University; 🇰🇷 Seoul, Korea, Republic of