Quality of Life
Conditions
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTDietary supplement
1 week of each intervention at bedtime with a 2-week washout period in between interventions
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chubon Lifestyle Score | 1 week | Total score ranges from 20 to 140 with higher scores being better quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | 1 week | Total Score score 0-24 with higher scores having greater degree of sleepiness |
| Multidimensional Fatigue Index -General Fatigue | 1-week | Index of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue. |
| Multidimensional Fatigue Index - Physical Fatigue | 1 week | Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue. |
| Multidimensional Fatigue Index - Mental Fatigue | 1 week | Index of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue. |
| Pittsburgh Sleep Quality Index Score | 1 week | Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | 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. |
| Wake After Sleep Onset | 1-week | Determined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min. |
| Sleep Latency | 1-week | Determined by Polysomnography - time it takes for a person to fall asleep in min |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Characteristic of Study Participant Characteristics of the study participant prior to any intervention | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 - Washout | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Baseline Characteristic of Study Participant |
|---|---|
| Age, Continuous | 59 Years STANDARD_DEVIATION 6 |
| Body mass index | 30 kg per meter square STANDARD_DEVIATION 10 |
| Glucose | 98 mg/dL STANDARD_DEVIATION 14 |
| Insomnia severtiy index | 21 scores on a scale. STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
| Wake after sleep onset | 75 minutes STANDARD_DEVIATION 33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Chubon Lifestyle Score
Total score ranges from 20 to 140 with higher scores being better quality of life
Time frame: 1 week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Chubon Lifestyle Score | Baseline | 103.9 score on a scale | Standard Error 2.5 |
| Dietary Supplement | Chubon Lifestyle Score | Follow up | 100.4 score on a scale | Standard Error 2.5 |
| Placebo | Chubon Lifestyle Score | Baseline | 100.9 score on a scale | Standard Error 2.4 |
| Placebo | Chubon Lifestyle Score | Follow up | 102.9 score on a scale | Standard Error 2.4 |
Secondary
Epworth Sleepiness Scale
Total Score score 0-24 with higher scores having greater degree of sleepiness
Time frame: 1 week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Epworth Sleepiness Scale | Baseline | 8.4 score on a scale | Standard Error 1.2 |
| Dietary Supplement | Epworth Sleepiness Scale | Follow up | 9.9 score on a scale | Standard Error 1.2 |
| Placebo | Epworth Sleepiness Scale | Baseline | 8.8 score on a scale | Standard Error 1.2 |
| Placebo | Epworth Sleepiness Scale | Follow up | 6.9 score on a scale | Standard Error 1.2 |
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.
Time frame: 1-week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Multidimensional Fatigue Index -General Fatigue | Baseline | 15.1 score on a scale | Standard Error 1 |
| Dietary Supplement | Multidimensional Fatigue Index -General Fatigue | Follow-up | 14.0 score on a scale | Standard Error 1 |
| Placebo | Multidimensional Fatigue Index -General Fatigue | Baseline | 14.7 score on a scale | Standard Error 1 |
| Placebo | Multidimensional Fatigue Index -General Fatigue | Follow-up | 13.4 score on a scale | Standard Error 1 |
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.
Time frame: 1 week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Multidimensional Fatigue Index - Mental Fatigue | Baseline | 11.7 score on a scale | Standard Error 1 |
| Dietary Supplement | Multidimensional Fatigue Index - Mental Fatigue | Follow-up | 12.4 score on a scale | Standard Error 1 |
| Placebo | Multidimensional Fatigue Index - Mental Fatigue | Baseline | 12.5 score on a scale | Standard Error 1 |
| Placebo | Multidimensional Fatigue Index - Mental Fatigue | Follow-up | 11.7 score on a scale | Standard Error 1 |
Secondary
Multidimensional Fatigue Index - Physical Fatigue
Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue.
Time frame: 1 week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Multidimensional Fatigue Index - Physical Fatigue | Baseline | 11.1 score on a scale | Standard Error 1.3 |
| Dietary Supplement | Multidimensional Fatigue Index - Physical Fatigue | Follow up | 9.5 score on a scale | Standard Error 1.3 |
| Placebo | Multidimensional Fatigue Index - Physical Fatigue | Baseline | 10.3 score on a scale | Standard Error 1.3 |
| Placebo | Multidimensional Fatigue Index - Physical Fatigue | Follow up | 11.3 score on a scale | Standard Error 1.3 |
Secondary
Pittsburgh Sleep Quality Index Score
Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values
Time frame: 1 week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Pittsburgh Sleep Quality Index Score | Baseline | 10.8 score on a scale | Standard Error 1 |
| Dietary Supplement | Pittsburgh Sleep Quality Index Score | Follow-up | 9.1 score on a scale | Standard Error 1 |
| Placebo | Pittsburgh Sleep Quality Index Score | Baseline | 10.5 score on a scale | Standard Error 1 |
| Placebo | Pittsburgh Sleep Quality Index Score | Follow-up | 8.3 score on a scale | Standard Error 1 |
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.
Time frame: 1-week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Sleep Efficiency | Baseline | 80 % of total sleep time | Standard Error 4 |
| Dietary Supplement | Sleep Efficiency | Follow-up | 80 % of total sleep time | Standard Error 4 |
| Placebo | Sleep Efficiency | Baseline | 80 % of total sleep time | Standard Error 4 |
| Placebo | Sleep Efficiency | Follow-up | 81 % of total sleep time | Standard Error 4 |
Other Pre-specified
Sleep Latency
Determined by Polysomnography - time it takes for a person to fall asleep in min
Time frame: 1-week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Sleep Latency | Follow-up | 24 Minutes | Standard Error 8 |
| Dietary Supplement | Sleep Latency | Baseline | 28 Minutes | Standard Error 8 |
| Placebo | Sleep Latency | Follow-up | 28 Minutes | Standard Error 8 |
| Placebo | Sleep Latency | Baseline | 32 Minutes | Standard Error 8 |
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.
Time frame: 1-week
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dietary Supplement | Wake After Sleep Onset | Baseline | 77 Minutes | Standard Error 21 |
| Dietary Supplement | Wake After Sleep Onset | Follow-up | 79 Minutes | Standard Error 21 |
| Placebo | Wake After Sleep Onset | Baseline | 71 Minutes | Standard Error 20 |
| Placebo | Wake After Sleep Onset | Follow-up | 72 Minutes | Standard Error 20 |