Does one-time ashwagandha intake improve cognitive function?

ISRCTN ISRCTN16835354
DOI https://doi.org/10.1186/ISRCTN16835354
Secondary identifying numbers AcuteAshwagandha2019
Submission date
31/10/2021
Registration date
02/11/2021
Last edited
03/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study arms
Ashwagandha (ASH) has long been used in the traditional Ayurvedic system of medicine to enhance memory and improve cognition. Human intervention studies have linked Ashwagandha to increased cognition in patients with early dementia or bipolar disorder, but studies in healthy populations are limited. It is currently unknown if one-time supplementation with Ashwagandha can improve cognitive performance in young healthy adults. The aim of this study is to examine the effect of acute ingestion of 400 mg of ashwagandha on executive function including general attention, sustained attention, attentional shifting, and/or working memory in young adults.

Who can participate?
Healthy men and women between the ages of 18 to 59 years

What does the study involve?
Participants will be randomly allocated to receive ASH or placebo (dummy) capsules, and then perform four cognitive function tests that assess a range of cognitive and executive function aspects.

What are the possible benefits and risks of participating?
The potential benefit of participating is an increase in executive functioning.

Where is the study run from?
Texas A&M University (USA)

When is the study starting and how long is it expected to run for?
April 2019 to November 2019.

Who is funding the study?
Specnova Inc. (USA)

Who is the main contact?
Dr Richard B. Kreider
rbkreider@tamu.edu

Contact information

Prof Richard Kreider
Scientific

Texas A&M University
675 Kimbrough Blvd.
Building #1542
College Station, TX
77843-4253
United States of America

ORCiD logoORCID ID 0000-0002-3906-1658
Phone +1 (0)979 458 1498
Email rbkreider@tamu.edu

Study information

Study designInterventional double-blinded randomized crossover controlled trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleThe effect of acute ashwagandha supplementation on cognitive function
Study objectivesAcute ashwagandha extract improves cognition.
Ethics approval(s)Approved 19/07/2019, Texas A&M University Institutional Review Board (517 Blocker Building, 155 Ireland Street, Texas A&M University, College Station, TX 778431, USA; +1 (0)979 458 4067; irb@tamu.edu), ref: IRB2019-0453D
Health condition(s) or problem(s) studiedImproving cognition in healthy individuals
InterventionSubjects consumed capsules containing 400 mg of a proprietary root and leaves extract of ashwagandha (NooGandha®, Specnova, Boca Raton, FL, USA) or capsules containing 400 mg of a wheat flour placebo (Placebo) once they have completed baseline testing with 8 ounces of water. A computer generated randomization to treatment was used. Once subjects were randomized to start, they followed the counter balance progression.
Intervention typeSupplement
Primary outcome measureThe Psychology Experiment Building Language (PEBL) software program (Version 2.1, http://pebl.sourceforge.net) was used to administer four cognitive function tests that assessed a range of cognitive and executive function aspects:
1. Berg-Wisconsin Card Sorting Task test (BCST) at baseline, 1, 2, 3, 4, 5 and 6 hours after ingestion
2. The Go/No-Go test (GNG) at baseline, 1, 2, 3, 4, 5 and 6 hours after ingestion
3. Sternberg Task Test (STT) at baseline, 1, 2, 3, 4, 5 and 6 hours after ingestion
4. Psychomotor Vigilance Task Test (PVTT) at baseline, 1, 2, 3, 4, 5 and 6 hours after ingestion
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/04/2019
Completion date10/11/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit59 Years
SexBoth
Target number of participants15
Total final enrolment15
Key inclusion criteriaApparently healthy males and females between the ages of 18 to 59 years were recruited to participate in the study.
All subjects were healthy and free from known:
1. Cognitive deficit conditions
2. Wheat flour allergies
3. Sleep disorders
4. Cardiovascular, metabolic, or pulmonary diseases
5. History of hypertension, migraine headaches, cardiac arrhythmias, or anxiety
6. Gastrointestinal reflux disease or ulcers
Key exclusion criteriaSubjects who were taking prescription medications in the month prior to the initiation of the study and/or were told by a physician to abstain or restrict caffeine and/or stimulant intake
Date of first enrolment20/07/2019
Date of final enrolment10/11/2019

Locations

Countries of recruitment

  • United States of America

Study participating centre

Texas A&M University
675 Kimbrough Blvd
Building #1542
College Station, Texas
77843-4253
United States of America

Sponsor information

Specnova Inc.
Industry

8609 Westwood Center Drive #110
Tysons Corner, VA
22182
United States of America

Phone +1 (0)720 245 4096
Email sebastian@specnova.com
Website https://www.specnova.com

Funders

Funder type

Industry

Specnova Inc.

No information available

Results and Publications

Intention to publish date31/12/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in peer-reviewed scientific journal.
IPD sharing planAll data generated or analyzed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 20/09/2022 03/01/2023 Yes No

Editorial Notes

03/01/2023: Publication reference added.
01/11/2021: Trial's existence confirmed by the Texas A&M University Institutional Review Board.