NCT02489747

Brief Summary

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of water extract from wheat Triticum aestivum L on cognitive and memory function. The investigators measured changes in cognitive function parameters, including CNT, WMT, K-MMSE, BCRS, PRMQ, PSS, SF-36 and BDNF

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

June 30, 2015

Last Update Submit

March 13, 2016

Conditions

Cognitive Function 1, Social

Keywords

cognitive functionCNTmemory functionTriticum aestivum Lwheat bran

Outcome Measures

Primary Outcomes (1)

  • Cognitive function as assessed by the visual learning test score of CNT (computerized neurocognitive test)

    baseline and 12 weeks

Secondary Outcomes (8)

  • Visual subset of WMT (working memory test)

    baseline and 12 weeks

  • Cognitive function as assessed by the CNT (Computerized Neurocognitive Test) score

    baseline and 12 weeks

  • Cognitive function as assessed by the Verbal subtest of WMT (Working Memory Test)

    baseline and 12 weeks

  • Cognitive function as assessed by the BCRS (Brief Cognitive Rating Sclae)

    baseline and 12 weeks

  • Memory function as assessed by the PRMQ (Prospective and Retrospective Memory Questionnaire)

    baseline and 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

WBE group

EXPERIMENTAL

wheat bran extract

Dietary Supplement: WBE

Placebo group

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

WBEDIETARY_SUPPLEMENT

wheat bran extract (3 g/day)

WBE group
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with subjective cognitive impairment
  • able to give informed consent

You may not qualify if:

  • history of underlying neurodegenerative disease
  • allergic or hypersensitive to any of the ingredients in the test products
  • history of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • history of alcohol or substance abuse
  • participation in any other clinical trials within past 2 months
  • laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 3, 2015

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

March 15, 2016

Record last verified: 2016-03