Quality of LifeSleepLiftNCT05323084
Effect of a Dietary Supplement on Quality of Life
A study testing Dietary supplement in people with Quality of Life, run by Pennington Biomedical Research Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Dietary supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2022to 7 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementDietary supplement
Also called Placebo
1 week of each intervention at bedtime with a 2-week washout period in between interventions
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Experimental | 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 Receives: Dietary Supplement: Dietary supplement |
| Placebo | Placebo comparator | 60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor Receives: Dietary Supplement: Dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chubon Lifestyle Score
Total score ranges from 20 to 140 with higher scores being better quality of life
Measured: 1 week
Secondary outcomes (5)
Pittsburgh Sleep Quality Index Score
Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values
Measured: 1 week
Epworth Sleepiness Scale
Total Score score 0-24 with higher scores having greater degree of sleepiness
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start25 Feb 2022
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1 week of treatment with a three component supplement or a placebo in people with insomina on two occasions separated by a 2-week washout
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Paula R Brantley, PhD, Study chair, Pennington Biomedical Research Center Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323084
- Sponsor's protocol ID
- PBRC 2020-039
- Acronym
- SleepLift
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2022
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available on approval of the PI
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Pilot Trial to Determine the Effect of an LSU Patented Dietary Herbal Supplement on Quality of Life
- ClinicalTrials.gov ID
- NCT05323084
- Acronym / sponsor ID
- SleepLift / PBRC 2020-039
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Louisiana State University Health Sciences Center in New Orleans
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 1 week of treatment with a three component supplement or a placebo in people with insomina on two occasions separated by a 2-week washout
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Experimental | Dietary Supplement: Dietary supplementGreen tea extract 5 grams, Chicory extract 1gram and collagen peptides 5 grams in 60ml with sugar, erythritol and 2% potassium sorbate and 1% flavor |
| Placebo | Placebo comparator | Dietary Supplement: Dietary supplement60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary supplementAlso: Placebo1 week of each intervention at bedtime with a 2-week washout period in between interventions | Dietary supplement | Dietary supplement, Placebo |
Primary outcome
Chubon Lifestyle Score
Time frame: 1 week
Total score ranges from 20 to 140 with higher scores being better quality of life
5 secondary outcomes
Pittsburgh Sleep Quality Index Score
Time frame: 1 week
Epworth Sleepiness Scale
Time frame: 1 week
Multidimensional Fatigue Index -General Fatigue
Time frame: 1-week
Multidimensional Fatigue Index - Physical Fatigue
Time frame: 1 week
Multidimensional Fatigue Index - Mental Fatigue
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Chubon Quality of Life Rating,Link provided by the sponsor.
- Validation of the Insomnia Severity IndexLink provided by the sponsor.
- Epworth Sleepiness scaleLink provided by the sponsor.
- Pittsburgh Sleep Quality IndexLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made available on approval of the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula R Brantley, PhD study chair
Pennington Biomedical Research Center Institutional Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement in people with Quality of Life, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chubon Lifestyle Score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.