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Effect of a Dietary Supplement on Quality of Life
NA trial testing Dietary supplement in Quality of Life in 10 participants. Completed in 7 September 2022.
| Lead sponsor | Pennington Biomedical Research Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 10 |
| Start date | 25 February 2022 |
| Primary completion | 7 September 2022 |
| Estimated completion | 7 September 2022 |
| Sites | 1 location across United States |
Pennington Biomedical Research Center — full company profile →
50 and older, any sex, with Quality of Life. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total score ranges from 20 to 140 with higher scores being better quality of life
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 103.9 | ± 2.5 |
| Placebo | 100.9 | ± 2.4 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 100.4 | ± 2.5 |
| Placebo | 102.9 | ± 2.4 |
Total Score ranges from 0 to 21 with higher sleep quality having lower numerical values
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 10.8 | ± 1 |
| Placebo | 10.5 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 9.1 | ± 1 |
| Placebo | 8.3 | ± 1 |
Total Score score 0-24 with higher scores having greater degree of sleepiness
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 8.4 | ± 1.2 |
| Placebo | 8.8 | ± 1.2 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 9.9 | ± 1.2 |
| Placebo | 6.9 | ± 1.2 |
Index of self-perceived general fatigue. Score range from 4 to 20 with high score indicative of more fatigue.
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 15.1 | ± 1.0 |
| Placebo | 14.7 | ± 1.0 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 14.0 | ± 1.0 |
| Placebo | 13.4 | ± 1.0 |
Index of self-perceived physical fatigue. Score range of 4 to 20 with higher score indicative more fatigue.
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 11.1 | ± 1.3 |
| Placebo | 10.3 | ± 1.3 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 9.5 | ± 1.3 |
| Placebo | 11.3 | ± 1.3 |
Index of self-perceived mental fatigue. Score ranges from 4 to 20 with higher scores indicative of more fatigue.
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 11.7 | ± 1 |
| Placebo | 12.5 | ± 1 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 12.4 | ± 1 |
| Placebo | 11.7 | ± 1 |
Determined by Polysomnography - time it takes for a person to fall asleep in min
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 28 | ± 8 |
| Placebo | 32 | ± 8 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 24 | ± 8 |
| Placebo | 28 | ± 8 |
Determined by polysomnography - total number of minutes a person is awake after having initially fallen asleep in min.
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 77 | ± 21 |
| Placebo | 71 | ± 20 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 79 | ± 21 |
| Placebo | 72 | ± 20 |
Determined by polysomnography - ratio of the total time spent asleep in a night compared to the total time spent in bed in percentage.
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 80 | ± 4 |
| Placebo | 80 | ± 4 |
| Group | Value | 95% CI |
|---|---|---|
| Dietary Supplement | 80 | ± 4 |
| Placebo | 81 | ± 4 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing