Effect of a Dietary Supplement on Quality of Life

Not Applicable

Completed

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, a finger oximeter 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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Dietary supplement	60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Dietary supplement	Dietary supplement	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

Primary Outcome Measures

Name	Time	Method
Chubon Lifestyle Score	1 week	Total score ranges from 20 to 140 with higher scores being better quality of life

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index Score	1 week	Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values
Epworth Sleepiness Scale	1 week	Total Score score 0-24 with higher scores having greater degree of sleepiness
Multidimensional Fatigue Index -General Fatigue	1-week	Index of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue.
Multidimensional Fatigue Index - Physical Fatigue	1 week	Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue.
Multidimensional Fatigue Index - Mental Fatigue	1 week	Index of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue.