Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07461402
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 35 to 70 years (inclusive)
* Experiencing sleep disturbances or sleep quality problems
* Willing and able to consume plant protein supplement daily for 30 days
* Willing and able to take adaptogen tablets daily for 30 days
* Able to provide written informed consent
* Able to complete daily sleep quality questionnaires
* Available for baseline and follow-up assessments
* Willing to maintain regular lifestyle habits during the study period
Exclusion Criteria:
* Age less than 35 years or greater than 70 years
* Known allergies or hypersensitivity to any study ingredients (pea protein, rice protein, hemp protein, Rhodiola rosea, Withania somnifera/ashwagandha, or excipients)
* Current use of prescription sleep medications or hypnotics
* Current use of other herbal supplements for sleep (washout period may be allowed)
* Serious or unstable medical conditions that could interfere with study participation or safety
* Severe psychiatric disorders requiring medication
* Uncontrolled metabolic diseases (for example, uncontrolled diabetes, thyroid disorders)
* Pregnancy or lactation
* Planning to become pregnant during the study period
* Participation in another clinical trial within the past 30 days
* Inability to understand or comply with study procedures
* Shift workers or individuals with irregular sleep schedules
* Recent major life events significantly affecting sleep patterns
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT07461402
Study Brief:
Protocol Section:
NCT07461402