Status:
COMPLETED
Effect of a Dietary Supplement on Quality of Life
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
Louisiana State University Health Sciences Center in New Orleans
Conditions:
Quality of Life
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The purpose of this research study is to evaluate the effect of a combination of 3 food components to improve the quality of life in people who have trouble sleeping. Ten subjects with insomnia will d...
Detailed Description
Each participant will be in the study for about 1 month. The questionnaires consist of Chubon Quality of Life Rating, the Multi-dimensional Fatigue Inventory, Insomnia Severity Index, the Epworth Slee...
Eligibility Criteria
Inclusion
- Healthy men or women \>50 years of age
- Usual bedtime between 9pm and midnight
- Insomnia for \>6months by ICSD-2 criteria
- Insomnia Severity Index score \>10 and Sleep-onset latency or Waking after sleep onset \>30 minutes
Exclusion
- Have diabetes mellitus
- Taking chronic medication not on a stable dose for \>1month
- Taking sedating or hypnotic medications
- Have a sleep disorder other than insomnia (like sleep apnea) Adults unable to consent Prisoners Pregnant women Individuals not yet adults
Key Trial Info
Start Date :
February 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05323084
Start Date
February 25 2022
End Date
September 7 2022
Last Update
December 16 2024
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808-4124