Effect of Ashwagandha supplementation on testosterone levels and vitality in healthy, overweight men

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000971336

Enrollment

Registered

2017-07-05

Start date

2017-12-12

Completion date

2018-02-08

Last updated

2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a double-blind, placebo-controlled, crossover study assessing the effects of Ashwagandha in 50 overweight adults presenting with mild-to-moderate symptoms of low energy/ vitality. Each participant receives both treatments (8 weeks of an Ashwagandha extract and placebo) and randomisation is used to determine the order in which the participant receives each treatment,( i.e. Ashwagandha followed by placebo, or placebo followed by Ashwagandha ). The Ashwagandha dosage is 2 tablets daily of BIPS technology Shoden (containing 10.5 mg of withanolide glycosides per tablet). Changes in mood, energy and vitality will be assessed via the completion of self-report measures, The effects of Ashwagandha on salivary levels of testosterone, cortisol, oestradiol, and DHEAs will also be examined.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

Male

Age

40 Years to 70 Years

Healthy volunteers

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

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

Outcome results