Effect of a Dietary Supplement on Quality of Life (SleepLift)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Dietary supplement: Dietary supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank L Greenway, MD; Phone Number: 12257632578; Email: frank.greenway@pbrc.edu
• Study Contact Backup: Name: John P Kirwan, PhD; Phone Number: 225-763-2513; Email: john.kirwan@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4124
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Dietary supplement; 1 week of each intervention at bedtime with a 2-week washout period in between interventions; Other Names: Placebo
Placebo Comparator: Placebo; 60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor	Dietary supplement: Dietary supplement; 1 week of each intervention at bedtime with a 2-week washout period in between interventions; Other Names: Placebo

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	Time to go to sleep and time awake after sleeping in minutes sleep diary, accelerometry	1-week
Safety Assessments	Chemistry panel, CBC	1-week
Janus Kinase 3	Measured in picograms/mL	1-week
Sleep Diary	Bedtime and time of awakening. Measured as the hour and minute during the day	1-week
Actigraphy	Sleep and awakening times recorded as time of day in hour and minute	1-week
Adverse Events	Description recorded with the relationship to study intervention	1-week
Fasting Glucose	mg/dL	1-week
Creatinine	mg/mL	1 week
Potassium	MMOL/L	1-week
Uric acid	mg/dL	1-week
Albumin	g/L	1-week
Calcium	mg/dL	1-week
Magnesium	mg/dL	1-week
Creatine phosphokinase	IU/L	1-week
Alanine-Leucine transerase	IU/L	1-week
Alkaline phosphatase	IU/L	1-week
Iron	micrograms/mL	1-week
Cholesterol	mg/dL	1- week
Triglycerides	mg/dL	1-week
High density lipoprotein cholesterol	mg/dL	1 week
Low density lipoprotein cholesterol	mg/dL	1 week
Hemoglobin	g/dL	1 week
Hemotocrit	Percent	1-week
Mean cell volume	Femtoliters	1-week
Platelet count	Thousands	1-week
White blood cell count	Thousands	1 week
Granulocytes	Thousands	1 week
Neutrophils	Thousands	1 week
Eosinophils	Thousands	1 week
Basophils	Thousands	1-week
Body Mass Index derived from height and weight	Kg/m2	1 week
Oximetry	oxygen desaturation	1 week

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Study Chair: Paula R Brantley, PhD, Pennington Biomedical Research Center Institutional Review Board

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PBRC 2020-039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available on approval of the PI
• IPD Sharing Time Frame: Study is expected to be done and report generated by June 2022
• IPD Sharing Access Criteria: Data can be accessed, if the use is approved by the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No