Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001551886
Ethics application status
Approved
Date submitted
1/10/2021
Date registered
15/11/2021
Date last updated
22/01/2024
Date data sharing statement initially provided
15/11/2021
Date results provided
22/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an Ashwagandha extract on stress and energy in middle-to-older age adults with self-reported stress and energy problems
Scientific title
Examining the efficacy and safety of a novel standardised Ashwagandha (Withania Somnifera) root extract in overweight middle-to-older age adults experiencing high stress and fatigue: a randomised, double-blind, placebo-controlled trial.
Secondary ID [1] 305351 0
None
Universal Trial Number (UTN)
U1111-1269-7899
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Stress 323677 0
Fatigue 323678 0
Inflammation 323680 0
Condition category
Condition code
Mental Health 321215 321215 0 0
Other mental health disorders
Alternative and Complementary Medicine 321216 321216 0 0
Herbal remedies
Inflammatory and Immune System 321291 321291 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ashwagandha extract (1 capsule taken orally, twice daily with or without food, delivering 400 mg a day for 12 weeks)

Adherence to capsule intake will be monitored through a mobile phone app and capsule return and count.
Intervention code [1] 321758 0
Treatment: Other
Comparator / control treatment
Placebo (containing maltodextrin) is matched to the ashwagandha extract capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 329003 0
Change in the Perceived Stress Scale
Timepoint [1] 329003 0
Day 0, weeks 4, 8, and 12 (primary endpoint) post-intervention commencement
Secondary outcome [1] 401132 0
Change in the Chalder Fatigue Scale
Timepoint [1] 401132 0
Day 0, weeks 4, 8, and 12 post-intervention commencement
Secondary outcome [2] 401134 0
Change in blood concentrations of total testosterone
Timepoint [2] 401134 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [3] 401367 0
Change in blood concentrations of free testosterone
Timepoint [3] 401367 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [4] 401368 0
Change in blood concentrations of oestradiol
Timepoint [4] 401368 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [5] 401369 0
Change in blood concentrations of luteinising hormone
Timepoint [5] 401369 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [6] 401370 0
Change in blood concentrations of dehydroepiandrosterone sulfate
Timepoint [6] 401370 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [7] 401371 0
Change in blood concentrations of malondialdehyde
Timepoint [7] 401371 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [8] 401372 0
Change in blood concentrations of glycated haemoglobin
Timepoint [8] 401372 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [9] 401373 0
Change in fasting blood glucose concentrations
Timepoint [9] 401373 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [10] 401374 0
Change in body mass index, which will be assessed as a composite of weight (in kilograms) measured using electronic standing scales and height (in metres) measured using a stadiometer.
Timepoint [10] 401374 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [11] 401375 0
Change in waist-to-hip ratio, which will be assessed as a composite of waist circumference measured using a tape measure at the narrowest point of the waist, and hip circumference measured using a tape measure at the widest point of the hips.
Timepoint [11] 401375 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [12] 401376 0
Change in strength as measured by a hand-held dynamometer
Timepoint [12] 401376 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [13] 401377 0
Change in heart rate variability, assessed by electrocardiogram (ECG) measurements using a heart rate monitor strap (Polar H10). After a 5-minute rest in a silent environment, ECG measurements will be performed for 10 minutes while the participant is in a seated position.
Timepoint [13] 401377 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [14] 402262 0
Change in liver function, assessed by a blood collection (safety measure)
Timepoint [14] 402262 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [15] 402263 0
Change in renal function, assessed by a blood collection (safety measure)
Timepoint [15] 402263 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [16] 402264 0
Change in complete blood count, assessed by a blood collection (safety measure)
Timepoint [16] 402264 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [17] 402265 0
Change in blood pressure, which will be assessed using a digital blood pressure monitor (safety measure)
Timepoint [17] 402265 0
Day 0 and week 12 post-intervention commencement
Secondary outcome [18] 402266 0
Change in physical function using the PROMIS-29
Timepoint [18] 402266 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [19] 402288 0
Change in anxiety using the PROMIS-29
Timepoint [19] 402288 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [20] 402289 0
Change in depression using the PROMIS-29
Timepoint [20] 402289 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [21] 402290 0
Change in fatigue using the PROMIS-29
Timepoint [21] 402290 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [22] 402291 0
Change in sleep disturbance using the PROMIS-29
Timepoint [22] 402291 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [23] 402292 0
Change in the ability to participate in social roles and activities using the PROMIS-29
Timepoint [23] 402292 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [24] 402293 0
Change in interest in sexual activity using the PROMIS-29
Timepoint [24] 402293 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [25] 402294 0
Change in pain interference using the PROMIS-29
Timepoint [25] 402294 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.
Secondary outcome [26] 402295 0
Change in pain intensity using the PROMIS-29
Timepoint [26] 402295 0
Day 0 and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 post-intervention commencement.

Eligibility
Key inclusion criteria
1) Healthy males and females aged between 40 and 75 years
2) Subjective report of low energy by answering ‘yes’ to the following question: Do you experience low energy or fatigue?
3) Currently experiencing high stress (as determined by a PSS scale score of 14 or higher)
4) A score of 9 or more on the PROMIS-29 fatigue subscale score
5) Stressor/anxiety has been present for greater than a month
6) Non-smoker
7) BMI between 25 and 35 kg/m2
8) Medication free over the previous 3 months
9) No plan to commence new treatments over the study period
10) No plan to change diet or physical activity or other significant lifestyle changes over the study period
11) Understand, willing, and able to comply with all study procedures
12) Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status
2) Blood profile (comprising complete blood count, liver function test, renal function test, and thyroid-stimulating hormone) containing elevated markers suggestive of a clinical condition/ disease and requiring further medical assessment.
3) Suffering from a diagnosed medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, renal disease, hepatic disease, genital anatomical deformities, abnormal secondary sexual characteristics, spinal cord injury, benign prostatic hypertrophy, acute genitourinary disorder or history of genital surgery, acute or chronic pain condition, or cancer/malignancy
4) Diagnosis of neurological or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury
5) Diagnosed erectile dysfunction or any physical disability that may limit sexual function
6) Taking vitamins or herbal supplements that are reasonably expected to influence study measures
7) Current or 12-month history of illicit drug abuse
8) Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, testosterone replacement therapy, levodopa, calcipotriene, or steroid medications
9) Change in medication in the last 3 months or an expectation to change during the study duration
10) Alcohol intake greater than 14 standard drinks per week
11) Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
12) Any significant surgeries over the last year
13) History of hypersensitivity to herbs, spices, or dietary supplement
14) Planned major lifestyle change in the next 3 months
15) Participation in any other clinical trial in the last 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 12 randomly permuted blocks, containing 10 participants per block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on previous studies on ashwagandha, with men and women participating, we are predicting an effect size of 0.5 compared to placebo. Based on this, a sample size of 51 per group is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, We will be recruiting 60 participants per group (120 participants in total). Based on the 120 people recruited, we have a suitable power to find an effect, even after dropouts.

A repeated-measures ANOVA will be conducted on the following to determine between-group differences (time x group interaction effects). Changes will be examined for the whole group and based on sex (male and female).

Analyses will be conducted to determine changes in the following:
a. PROMIS-29 scores: baseline, mean score for weeks 1 to 4, 5 to 8, and 9 to 12
b. Perceived Stress Scale: change in total scores: Baseline, weeks 4, 8, and 12
c. Chalder Fatigue Scale: baseline, weeks 4, 8, and 12
d. Total testosterone: baseline to week 12
e. Free testosterone: baseline to week 12
f. Oestradiol: baseline to week 12
g. Luteinising hormone: baseline to week 12
h. Dehydroepiandrosterone sulfate: baseline to week 12
i Malondialdehyde: baseline to week 12
j. Glycated haemoglobin: baseline to week 12
k. Fasting glucose: baseline to week 12
l. Body mass index: baseline to week 12
m. Waist-to-hip ratio: baseline to week 12
n Strength test as measure by a hand-held dynamometer: baseline to week 12
o. Heart rate variability: baseline to week 12
p. Liver function, renal function, complete blood count, and blood pressures (safety measures): baseline to week 12

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2021
Actual
1/02/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
9/06/2022
Date of last data collection
Anticipated
30/09/2022
Actual
28/09/2022
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 309722 0
Commercial sector/Industry
Name [1] 309722 0
Verdure Sciences Pty Ltd
Country [1] 309722 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 310742 0
None
Name [1] 310742 0
Address [1] 310742 0
Country [1] 310742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309484 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 309484 0
Ethics committee country [1] 309484 0
Australia
Date submitted for ethics approval [1] 309484 0
14/09/2021
Approval date [1] 309484 0
17/11/2021
Ethics approval number [1] 309484 0
0092E_2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114306 0
Dr Adrian Lopresti
Address 114306 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 114306 0
Australia
Phone 114306 0
+61 08 94487376
Fax 114306 0
Email 114306 0
[email protected]
Contact person for public queries
Name 114307 0
Adrian Lopresti
Address 114307 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 114307 0
Australia
Phone 114307 0
+61 08 94487376
Fax 114307 0
Email 114307 0
[email protected]
Contact person for scientific queries
Name 114308 0
Adrian Lopresti
Address 114308 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 114308 0
Australia
Phone 114308 0
+61 08 94487376
Fax 114308 0
Email 114308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExploring the efficacy and safety of a novel standardized ashwagandha (Withania somnifera) root extract (Witholytin) in adults experiencing high stress and fatigue in a randomized, double-blind, placebo-controlled trial.2023https://dx.doi.org/10.1177/02698811231200023
N.B. These documents automatically identified may not have been verified by the study sponsor.