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

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Pennington Biomedical Research Center

Status

Completed

Conditions

Quality of Life

Treatments

Dietary Supplement: Dietary supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT05323084
PBRC 2020-039

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

9 participants in 2 patient groups, including a placebo group

Dietary supplement
Experimental group
Description:
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
Treatment:
Dietary Supplement: Dietary supplement
Placebo
Placebo Comparator group
Description:
60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor
Treatment:
Dietary Supplement: Dietary supplement

Trial contacts and locations

1

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Central trial contact

John P Kirwan, PhD; Frank L Greenway, MD

Data sourced from clinicaltrials.gov

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