150 Day
Melatonin Impact on Recovery and Vitality
| STUDY TITLE | Melatonin Impact on Recovery and Vitality |
|---|---|
| Submitted under umbrella | |
| Date submitted |
- |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
|
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
This clinical trial investigates the effects of nightly melatonin supplementation on recovery, vitality, and sexual satisfaction among adults. Participants will consume melatonin each evening to evaluate potential improvements in recovery and vitality as well as any changes in sexual satisfaction across the duration of the trial. |
| Participant engagement length |
150 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$0 |
| Included products & services |
VitaHustle Sleep Melatonin Gummies: $14
: $0
|
| Outcome measures |
PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
Yes |
| Recruitment jurisdictions |
United States, United Kingdom |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this challenge:
Amidst growing interest and diverse claims about melatonin's benefits on social media and wellness blogs, rigorous study is needed. Scholarly research suggests melatonin may enhance sleep quality, which in turn could impact overall vitality and sexual satisfaction. However, substantial hype without sufficient high-quality evidence has left a gap in our understanding. This challenge aims to bridge this gap, combining scientific rigor with the engaging format of a social media challenge to yield clear, actionable insights.
My Objective for You:
To rigorously evaluate how nightly intake of VitaHustle Sleep Melatonin Gummies affects your recovery, vitality, and sexual satisfaction using the PROMIS Sleep-Related Impairment Survey from baseline to day 150.
Aims & Objectives:
Our primary aim is to scientifically assess the impact of melatonin on recovery, vitality, and sexual satisfaction. We will track changes from baseline to endpoint using validated survey instruments to ensure reliable and meaningful results.
Significance & Impact:
This challenge holds significant potential to scientifically confirm or challenge popular claims about melatonin's benefits. By participating, you contribute to a body of knowledge that could shape recommendations for melatonin use in promoting better sleep and, by extension, improving daily functioning and satisfaction in life. Limitations include the trial's duration and reliance on self-reported data, which we aim to mitigate through methodological rigor.
The Intervention
Included Products & Services
Product Name: VitaHustle Sleep Melatonin Gummies
Quantity included: 50
Price: $14.00
Product Description: Jam-packed with melatonin, chamomile, and lemon balm, these gummies help you relax, drift off quicker, and get better quality sleep. Each gummy contains 5 mg of melatonin so you can rest easy. Blueberry Lemonade Flavor. 50 Gummies.
Product Image:
Ingredients:
Product Safety:
Product Name:
Quantity included:
Price: $0.00
Product Description:
Product Image:
Ingredients:
Product Safety:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Study Design & Experience
Statistical Analysis Plan
Limitations & Justification
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
Suitability for Pay to Participate Model
Human Subjects Protection Questionnaire
Logging
Logging
| Date | Event | Message | Name |
|---|---|---|---|
| No records found. | |||