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Completed

NCT Number: NCT05323084

Effect of a Dietary 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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Supplement

Dietary Supplement

1 week of each intervention at bedtime with a 2-week washout period in between interventions

Other names: Placebo

Primary outcomes

  1. Chubon Lifestyle Score

    Time frame: 1 week

    Total score ranges from 20 to 140 with higher scores being better quality of life

Secondary outcomes

  1. Pittsburgh Sleep Quality Index Score

    Time frame: 1 week

    Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values

  2. Epworth Sleepiness Scale

    Time frame: 1 week

    Total Score score 0-24 with higher scores having greater degree of sleepiness

  3. Multidimensional Fatigue Index -General Fatigue

    Time frame: 1-week

    Index of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue.

  4. Multidimensional Fatigue Index - Physical Fatigue

    Time frame: 1 week

    Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue.

  5. Multidimensional Fatigue Index - Mental Fatigue

    Time frame: 1 week

    Index of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue.

Other outcomes

  1. Sleep Latency

    Time frame: 1-week

    Determined by Polysomnography - time it takes for a person to fall asleep in min

  2. Wake After Sleep Onset

    Time frame: 1-week

    Determined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min.

  3. Sleep Efficiency

    Time frame: 1-week

    Determined by polysomnography - ratio of the total time spent asleep in a night compared to the total time spent in bed in percentage.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

Registry information

Official study title

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

Acronym: SleepLift

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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