Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000971336
Ethics application status
Approved
Date submitted
3/07/2017
Date registered
5/07/2017
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Ashwagandha supplementation on testosterone levels and vitality in healthy, overweight men
Scientific title
Effect of Ashwagandha supplementation on testosterone levels and vitality in healthy, overweight males with mild to moderate symptoms of fatigue or reduced vitality – a randomised, double-blind, placebo-controlled study
Secondary ID [1] 292251 0
None
Universal Trial Number (UTN)
U1111-1198-2075
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Energy and Vitality 303756 0
Hormonal changes 303758 0
Wellbeing 303762 0
Condition category
Condition code
Mental Health 303129 303129 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 303134 303134 0 0
Herbal remedies
Metabolic and Endocrine 303135 303135 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two tablets containing BIPS technology Shoden (containing 10.5 mg of withanolide glycosides per tablet) will be consumed once daily (two hours away from food, preferably after dinner) for 8 weeks by healthy, overweight males aged between 40 and 70 years with mild to moderate symptoms of fatigue or reduced vitality. Adherence to tablet intake will be monitored through tablet return and count. In this crossover trial, there is no washout period between treatment arms.
Intervention code [1] 298416 0
Treatment: Other
Comparator / control treatment
Placebo is matched to the Ashwagandha capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 302507 0
Change in total score as assessed by the Ageing Males’ Symptoms (AMS) self-report measure.
Timepoint [1] 302507 0
Weeks 0, 4 and 8 (week 8 is primary endpoint)
Primary outcome [2] 302652 0
Change in total mood disturbance score as assessed by the Profile of Mood States, Short Form
Timepoint [2] 302652 0
Weeks 0, 4 and 8 (week 8 is primary endpoint)
Secondary outcome [1] 336257 0
Change in sub-scale scores as assessed by the Profile of Mood States, Short Form (subscales scores include Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigour-Activity, and Friendliness)
Timepoint [1] 336257 0
Weeks 0, 4 and 8 (week 8 is primary endpoint)
Secondary outcome [2] 336664 0
Change in sub-scale scores comprising psychological, somatic and sexual symptoms, as assessed by the Ageing Males’ Symptoms (AMS) self-report measure.
Timepoint [2] 336664 0
Weeks 0, 4 and 8 (week 8 is primary endpoint)
Secondary outcome [3] 336665 0
Change in salivary testosterone levels
Timepoint [3] 336665 0
Weeks 0 and 8
Secondary outcome [4] 336666 0
Change in salivary cortisol levels
Timepoint [4] 336666 0
Weeks 0 and 8
Secondary outcome [5] 336667 0
Change in salivary DHEAs
Timepoint [5] 336667 0
Weeks 0 and 8
Secondary outcome [6] 336668 0
Change in salivary oestradiol levels
Timepoint [6] 336668 0
Weeks 0 and 8

Eligibility
Key inclusion criteria
1. Healthy males aged between 40 and 70 years
2. Mild to moderate symptoms of fatigue or reduced vitality as measured via a validated questionnaire (i.e., a score above the 60th percentile in the Profile of Mood Symptoms questionnaire – Total score or Fatigue-Inertia score or Vigour-Activity score)
3. Medication-free for at least 3 months
4. Non-smoker
5. BMI between 25 and 35
Minimum age
40 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suffer from a diagnosable mental health disorder e.g., depression, anxiety disorder, eating disorder, psychosis/ schizophrenia.
2. Suffer from medical illnesses including diabetes, autoimmune diseases, cardiovascular disease, hypertension, chronic fatigue syndrome, asthma.
3. Have suffered from an infection or illness over the last month (includes the common cold)
4. Alcohol consumption > 14 standard drinks per week
5. Current or history of illicit drug abuse
6. Currently taking any herbal preparations
7. Hypersensitive to ashwagandha, herbal supplements, or other herbs & spices

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)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 50) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 50 into either group 1 or 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this crossover study, participants will be given an opportunity to take both Ashwagandha and placebo. This ensures we have a sample size of 50 in each group. With a predicted moderate effect size of 0.5, this study is sufficiently powered to detect group differences.

Pre and post analyses will be conducted to determine changes in the following:
1. Total and subscale scores determined by the administration of the Ageing Males’ Symptoms
2. Subscale scores determined by the administration of the Profile of Mood States, Short Form
3. Change in salivary testosterone, cortisol, oestradiol, and DHEAs levels

Comparisons will be made between the periods when participants were taking a placebo versus periods on Ashwagandha to determine if there are any significant differences in the above measures.

These analyses will be conducted via a repeated measures analysis of variance via SPSS

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2017
Actual
12/12/2017
Date of last participant enrolment
Anticipated
31/10/2017
Actual
8/02/2018
Date of last data collection
Anticipated
28/02/2018
Actual
2/05/2018
Sample size
Target
50
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 296797 0
Commercial sector/Industry
Name [1] 296797 0
Arjuna Natural Extracts Limited
Country [1] 296797 0
India
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 295783 0
Commercial sector/Industry
Name [1] 295783 0
Arjuna Natural Extracts Limited
Address [1] 295783 0
PB No : 126,
Bank Road, Alwaye,
Kerala, India
PIN : 683 101
Country [1] 295783 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298032 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 298032 0
Ethics committee country [1] 298032 0
Australia
Date submitted for ethics approval [1] 298032 0
21/04/2017
Approval date [1] 298032 0
30/05/2017
Ethics approval number [1] 298032 0
2017/076

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

Contacts
Principal investigator
Name 75758 0
Prof Peter Drummond
Address 75758 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 75758 0
Australia
Phone 75758 0
+61 8 9360 2415
Fax 75758 0
Email 75758 0
[email protected]
Contact person for public queries
Name 75759 0
Adrian Lopresti
Address 75759 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 75759 0
Australia
Phone 75759 0
+61411969797
Fax 75759 0
Email 75759 0
[email protected]
Contact person for scientific queries
Name 75760 0
Adrian Lopresti
Address 75760 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 75760 0
Australia
Phone 75760 0
+61411969797
Fax 75760 0
Email 75760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.