Effect of a Dietary Supplement on Quality of Life

Study Overview
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Brief Summary
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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, a finger oximeter and a sleep study will be done before and after each treatment week.

Detailed Description
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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 an actigraph and polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, Janus Kinase measured in the blood and a buffy coat will be archived.

Official Title
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A Cross-over Pilot Trial to Determine the Effect of an LSU Patented Dietary Herbal Supplement on Quality of Life

Conditions
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Quality of Life

Intervention / Treatment
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* Dietary Supplement: Dietary supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br>Green tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor | Dietary Supplement: Dietary supplement<br>* 1 week of each intervention at bedtime with a 2-week washout period in between interventions<br>* Other names: Placebo;|
| Placebo Comparator: Placebo<br>60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor | Dietary Supplement: Dietary supplement<br>* 1 week of each intervention at bedtime with a 2-week washout period in between interventions<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chubon / A Quality-of-Life Rating Scale | Total score ranges from 20 to 140 with higher scores being better quality of life | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | Total score ranges from 0 to 28 and higher numbers mean more insomnia | 1 week | 
| Pittsburgh Sleep Quality Index | Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values | 1 week | 
| Epworth Sleepiness Scale | Total Score score 0-24 with higher scores having greater degree of sleepiness | 1 week |