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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | 60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement | Dietary Supplement | 1 week of each intervention at bedtime with a 2-week washout period in between interventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chubon Lifestyle Score | Total score ranges from 20 to 140 with higher scores being better quality of life | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index Score | 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula R Brantley, PhD | Pennington Biomedical Research Center Institutional Review Board | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808-4124 | United States |
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| Label | URL |
|---|---|
| Chubon Quality of Life Rating, | View source |
| Validation of the Insomnia Severity Index | View source |
| Epworth Sleepiness scale |
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De-identified data will be made available on approval of the PI
Study is expected to be done and report generated by June 2022
Data can be accessed, if the use is approved by the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietary Supplement First and Placebo Second | 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: 1 week of each intervention at bedtime with a 2-week washout period in between interventions |
| FG001 | Placebo First Dietary Supplement Second | 60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 - Washout |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Characteristic of Study Participant | Characteristics of the study participant prior to any intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chubon Lifestyle Score | Total score ranges from 20 to 140 with higher scores being better quality of life | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week |
|
up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 1 week of each intervention at bedtime with a 2-week washout period in between interventions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prachi Singh | Pennington Biomedical Research Institute | 15072068331 | prachi.singh@pbrc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2021 | Sep 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 23, 2021 | Sep 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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
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Liquid that looks and tastes the same, but only one has the three food components. The order in which the subjects get the 3-component supplement and the placebo is randomly assigned and balanced.
|
| 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 |
| 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 |
| Pittsburgh Sleep Quality Index | View source |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body mass index | Mean | Standard Deviation | kg per meter square |
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| Glucose | Mean | Standard Deviation | mg/dL |
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| Wake after sleep onset | Wake after sleep onset is determined by 7-day accelerometry and measures total number of minutes a person is awake after having initially fallen asleep in min. Higher values indicate poor sleep. | Mean | Standard Deviation | minutes |
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| Insomnia severtiy index | Insomnia severity index ranges from 0 to 28. Scores above 15 are considered to be clinically significant insomnia. | Mean | Standard Deviation | scores on a scale. |
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| Secondary | Pittsburgh Sleep Quality Index Score | Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week |
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| Secondary | Epworth Sleepiness Scale | Total Score score 0-24 with higher scores having greater degree of sleepiness | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week |
|
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| Secondary | Multidimensional Fatigue Index -General Fatigue | Index of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue. | Posted | Least Squares Mean | Standard Error | score on a scale | 1-week |
|
|
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| Secondary | Multidimensional Fatigue Index - Physical Fatigue | Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue. | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week |
|
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| Secondary | Multidimensional Fatigue Index - Mental Fatigue | Index of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue. | Posted | Least Squares Mean | Standard Error | score on a scale | 1 week |
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| Other Pre-specified | Sleep Latency | Determined by Polysomnography - time it takes for a person to fall asleep in min | Posted | Least Squares Mean | Standard Error | Minutes | 1-week |
|
|
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| Other Pre-specified | Wake After Sleep Onset | Determined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min. | Posted | Least Squares Mean | Standard Error | Minutes | 1-week |
|
|
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| Other Pre-specified | 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. | Posted | Least Squares Mean | Standard Error | % of total sleep time | 1-week |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Placebo | 60ml of water, sugar, erythritol, 2% potassium sorbate, and 1% flavor Dietary supplement: 1 week of each intervention at bedtime with a 2-week washout period in between interventions | 0 | 10 | 0 | 10 | 0 | 10 |
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