Effect of a Dietary Supplement on Quality of Life

Quality of Life Clinical Trial

— SleepLift  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323084
• Other study ID #: PBRC 2020-039
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: September 7, 2022

Study information

• Verified date: July 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 7, 2022
• Est. primary completion date: September 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

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

Related Conditions & MeSH terms

• Quality of Life

Intervention

Dietary Supplement:
• Dietary supplement
1 week of each intervention at bedtime with a 2-week washout period in between interventions

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Polysomnography	Time to go to sleep and time awake after sleeping in minutes sleep diary, accelerometry	1-week
Other	Safety Assessments	Chemistry panel, CBC	1-week
Other	Janus Kinase 3	Measured in picograms/mL	1-week
Other	Sleep Diary	Bedtime and time of awakening. Measured as the hour and minute during the day	1-week
Other	Actigraphy	Sleep and awakening times recorded as time of day in hour and minute	1-week
Other	Adverse Events	Description recorded with the relationship to study intervention	1-week
Other	Fasting Glucose	mg/dL	1-week
Other	Creatinine	mg/mL	1 week
Other	Potassium	MMOL/L	1-week
Other	Uric acid	mg/dL	1-week
Other	Albumin	g/L	1-week
Other	Calcium	mg/dL	1-week
Other	Magnesium	mg/dL	1-week
Other	Creatine phosphokinase	IU/L	1-week
Other	Alanine-Leucine transerase	IU/L	1-week
Other	Alkaline phosphatase	IU/L	1-week
Other	Iron	micrograms/mL	1-week
Other	Cholesterol	mg/dL	1- week
Other	Triglycerides	mg/dL	1-week
Other	High density lipoprotein cholesterol	mg/dL	1 week
Other	Low density lipoprotein cholesterol	mg/dL	1 week
Other	Hemoglobin	g/dL	1 week
Other	Hemotocrit	Percent	1-week
Other	Mean cell volume	Femtoliters	1-week
Other	Platelet count	Thousands	1-week
Other	White blood cell count	Thousands	1 week
Other	Granulocytes	Thousands	1 week
Other	Neutrophils	Thousands	1 week
Other	Eosinophils	Thousands	1 week
Other	Basophils	Thousands	1-week
Other	Body Mass Index derived from height and weight	Kg/m2	1 week
Other	Oximetry	oxygen desaturation	1 week
Primary	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	Insomnia Severity Index	Total score ranges from 0 to 28 and higher numbers mean more insomnia	1 week
Secondary	Pittsburgh Sleep Quality Index	Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values	1 week
Secondary	Epworth Sleepiness Scale	Total Score score 0-24 with higher scores having greater degree of sleepiness	1 week

External Links

•   Chubon Quality of Life Rating,
•   Epworth Sleepiness scale
•   Pittsburgh Sleep Quality Index
•   Validation of the Insomnia Severity Index