Investigation of the effects of Probiotics along with Exercise on the sleep quality among Indian Medical undergraduates.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)
Study Overview
Brief Summary
Poor sleep quality is common among medical undergraduate students and is associated with stress, lifestyle factors, and impaired health. Regular physical exercise is known to improve sleep quality, while probiotics have been suggested to influence sleep and mental well-being through modulation of inflammatory and physiological processes.
This interventional study aims to assess the effect of probiotic supplementation along with regular exercise on sleep quality among medical undergraduate students and to compare the outcomes with exercise alone.
The study will be conducted among 60 undergraduate medical students aged 18–21 years at Jawaharlal Nehru Medical College, Belagavi, with impaired sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI). Participants will be randomly allocated into two groups: Control group will receive a standardized exercise regimen with placebo, and Experimental group will receive the same exercise regimen along with daily multi-strain probiotic supplementation for a period of eight weeks. Students with chronic medical illnesses, psychiatric conditions, or medication use affecting study outcomes will be excluded.
Sleep quality will be assessed using PSQI at baseline and at the end of the intervention. Blood samples will be collected at baseline and after eight weeks to assess inflammatory markers including TNF-alpha, IL-6, and IL-10. Pre- and post-intervention outcomes will be compared within and between the two groups to evaluate the effect of probiotics combined with exercise on sleep quality.
This study aims to expand the existing knowledge about probiotics and their effects on psychological well-being (psychobiotics). This can provide insights into the potential of probiotics and exercise as non-pharmacological interventions for sleep disorders, contributing to a better understanding of the gut-brain axis and its role in sleep regulation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 25.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy medical undergraduate students who are willing to comply with study protocols -Physically able to perform moderate exercise -Baseline poor or suboptimal sleep quality (PSQI more than 5).
Exclusion Criteria
- •Diagnosed sleep disorders -Current psychiatric illness or use of psychotropic medications -GI impaired students already consuming probiotics -Regular use of sleep altering substances and devices -Chronic medical illnesses affecting sleep -Autoimmune disorders.
Outcomes
Primary Outcomes
Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)
Time Frame: Pittsburg Sleep Quality Index (PSQI) Score- assessed at baseline, 4 weeks and 8 weeks | Inflammatory markers (IL-10 and IL-6) will be assessed at Baseline and at the end of 8 weeks.
Secondary Outcome - Change in inflammatory markers (IL-10 and IL-6) measured using pre and post intervention blood samples
Time Frame: Pittsburg Sleep Quality Index (PSQI) Score- assessed at baseline, 4 weeks and 8 weeks | Inflammatory markers (IL-10 and IL-6) will be assessed at Baseline and at the end of 8 weeks.
Secondary Outcomes
- Change in sleep quality, assessed pre- and post- intervention using Pittsburg Sleep Quality Index (PSQI)
Investigators
Nirmiti Bhaven Mahadevia
MBBS Student, Jawaharlal Nehru Medical College, KAHER, Belagavi