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, 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 a polysomnography. At the end of each treatment period subjects will have a chemistry panel, a CBC, and a buffy coat will be archived.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Latency	Determined by Polysomnography - time it takes for a person to fall asleep in min	1-week
Wake After Sleep Onset	Determined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min.	1-week
Sleep Efficiency	Determined by polysomnography - ratio of the total time spent asleep in a night compared to the total time spent in bed in percentage.	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): February 25, 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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

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