N/A
N=10
Effect of a Dietary Supplement on Quality of Life
Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT05323084 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Chubon Lifestyle Score — 103.9; 100.9; 100.4; 102.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dietary supplement (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chubon Lifestyle Score |
103.9; 100.9; 100.4; 102.9 | — |
| SECONDARY Pittsburgh Sleep Quality Index Score |
10.8; 10.5; 9.1; 8.3 | — |
| SECONDARY Epworth Sleepiness Scale |
8.4; 8.8; 9.9; 6.9 | — |
| SECONDARY Multidimensional Fatigue Index -General Fatigue |
15.1; 14.7; 14.0; 13.4 | — |
| SECONDARY Multidimensional Fatigue Index - Physical Fatigue |
11.1; 10.3; 9.5; 11.3 | — |
| SECONDARY Multidimensional Fatigue Index - Mental Fatigue |
11.7; 12.5; 12.4; 11.7 | — |
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 drink 2 ounces of the supplement or a placebo for 1 week and after a 2 weeks washout period, will take the treatment they did not take the first week. Questionnaires to evaluate quality of life, and a sleep study will be done before and after each treatment week.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05323084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.