Does one-time ashwagandha intake improve cognitive function?
ISRCTN | ISRCTN16835354 |
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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
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
Scientific
Texas A&M University
675 Kimbrough Blvd.
Building #1542
College Station, TX
77843-4253
United States of America
0000-0002-3906-1658 | |
Phone | +1 (0)979 458 1498 |
rbkreider@tamu.edu |
Study information
Study design | Interventional double-blinded randomized crossover controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised cross over trial |
Study setting(s) | Other |
Study type | Other |
Participant information sheet | No participant information sheet available |
Scientific title | The effect of acute ashwagandha supplementation on cognitive function |
Study objectives | Acute 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) studied | Improving cognition in healthy individuals |
Intervention | Subjects 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 type | Supplement |
Primary outcome measure | The 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 measures | There are no secondary outcome measures |
Overall study start date | 01/04/2019 |
Completion date | 10/11/2019 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 59 Years |
Sex | Both |
Target number of participants | 15 |
Total final enrolment | 15 |
Key inclusion criteria | Apparently 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 criteria | Subjects 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 enrolment | 20/07/2019 |
Date of final enrolment | 10/11/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Building #1542
College Station, Texas
77843-4253
United States of America
Sponsor information
Industry
8609 Westwood Center Drive #110
Tysons Corner, VA
22182
United States of America
Phone | +1 (0)720 245 4096 |
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sebastian@specnova.com | |
Website | https://www.specnova.com |
Funders
Funder type
Industry
No information available
Results and Publications
Intention to publish date | 31/12/2021 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Published as a supplement to the results publication |
Publication and dissemination plan | Planned publication in peer-reviewed scientific journal. |
IPD sharing plan | All 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.