Clinical trial NCT05323084: Effect of a Dietary Supplement on Quality of Life
Official title: A Cross-over Pilot Trial to Determine the Effect of an LSU Patented Dietary Herbal Supplement on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2022-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1 week of treatment with a three component supplement or a placebo in people with insomina on two occasions separated by a 2-week washout
Primary purpose: OTHER

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 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.

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 Sleepiness, Pittsburgh Sleep Quality Index. Subjects will be screened with a medical questionnaire, vital signs, height, weight, oximetry to identify sleep apnea, a CBC and chemistry panel and the Insomnia severity Index. Weight, vital signs, adverse event questioning, dispensing and collection of test material will be done at each visit. During each treatment week subjects will wear an actigraph, keep a sleep diary and at the beginning and end of each treatment week subjects will have a polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, and a buffy coat will be archived.

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

Primary outcomes:
measure: Chubon Lifestyle Score
timeFrame: 1 week
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index Score
timeFrame: 1 week
measure: Epworth Sleepiness Scale
timeFrame: 1 week
measure: Multidimensional Fatigue Index -General Fatigue
timeFrame: 1-week
measure: Multidimensional Fatigue Index - Physical Fatigue
timeFrame: 1 week
measure: Multidimensional Fatigue Index - Mental Fatigue
timeFrame: 1 week
Other outcomes:
measure: Sleep Latency
timeFrame: 1-week
measure: Wake After Sleep Onset
timeFrame: 1-week
measure: Sleep Efficiency
timeFrame: 1-week
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center Institutional Review Board
name: Paula R Brantley, PhD
role: STUDY_CHAIR
References: