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The purpose of this research study is test if a study that asks older adults with sleep problems to consume tart cherry products is feasible and determine if it can change sleep patterns. This study is a total of 12 weeks. Participants will be asked to consume tart cherry juice for 4 weeks and the placebo juice for 4 weeks, while wearing a digital monitor that measures sleep. Blood (about 3 teaspoons) and urine (about 2 tablespoons) samples will be taken before and after consuming both juices to measure certain biological markers related to sleep.
The overall goal of this study is to determine feasibility of a tart cherry juice intervention in older adults, and generate preliminary data of outcomes and mechanisms related to sleep. We propose a 2-arm randomized, double-blind, cross-over study in 20 older adults with self-reported insomnia. Participants will consume 240 mL of tart cherry juice or placebo (calorically matched to the tart cherry juice beverage, but theoretically devoid of melatonin, tryptophan, magnesium and flavonoids), twice/evening for 4 weeks in a randomly assigned order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tart Cherry Juice | Experimental |
| |
| Placebo Juice | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tart Cherry Juice | Other | Individuals will be asked to consume 240 mL (i.e., 8 ounces) at approximately 5 pm and 240 mL (i.e., 8 ounces) of tart cherry juice at approximately 1 hour before bedtime for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Number of individuals that need to be screened to be enrolled that are randomized to the intervention. | From first contact until randomization |
| Attrition | Number of individuals randomized that withdraw from the intervention after randomization and starting the intervention product. | From randomization until end of 12 week study |
| Compliance | The number of doses consumed/ the number of intended doses (%) | From randomization until end of 12 week study |
| Ability to Collect Data | The percentage of missing data points from electronic capture data devices. | From enrollment to end of 12 week study |
| Practicality | Self-reported willingness to continue the dietary regimen after study completion. | Week 12 study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quantity (minutes) | From enrollment to end of 12 week study | |
| Sleep Quality | The validated self-report questionnaire, the Pittsburg Sleep Quality Index, will be used as a measure of sleep quality. This instrument ranges from 0-21 points, with higher scores indicating worse sleep quality. |
| Measure | Description | Time Frame |
|---|---|---|
| Mood | A validated self-report questionnaire, the Center for Epidemiological Studies Depression Scale, will be used to evaluate mood/depressive symptom severity. This instrument ranges from 0-60 points, with higher scores indicating more severe symptoms of depression. | Week 1, Week 3, Week 5, Week 8, Week 10, Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Millar, PhD | Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew Rehabilitation Center | Roslindale | Massachusetts | 02131 | United States |
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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 | Jan 31, 2025 | Feb 11, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Placebo juice | Other | Individuals will be asked to consume 240 mL (i.e., 8 ounces) at approximately 5 pm and 240 mL (i.e., 8 ounces) of placebo juice at approximately 1 hour before bedtime for 4 weeks. |
|
| Week 1, Week 5, Week 8, Week 12 |
| Urinary melatonin metabolite (6-sulphatoxymelatonin) | Week 1, Week 5, Week 8, Week 12 |
| Serum Marker of Serotonin (kynurenine/tryptophan ratio in blood) | Week 1, Week 5, Week 8, Week 12 |
| Urinary Cortisol | Week 1, Week 5, Week 8, Week 12 |
| Interleukin 6 in blood | Week 1, Week 5, Week 8, Week 12 |
| C-reactive Protein in Blood | Week 1, Week 5, Week 8, Week 12 |
| Stress |
The validated self-report questionnaire, the Perceived Stress Scale, will be used to evaluate stress. This instrument ranges from 0-56 points, with higher scores indicating more stress. |
| Week 1, Week 3, Week 5, Week 8, Week 10, Week 12 |
| Pain | The validated self-report questionnaire, the Geriatric Pain Measure, will be used to evaluate pain. This instrument ranges from 0-42 points, with higher scores indicating more severity of pain. | Week 1, Week 3, Week 5, Week 8, Week 10, Week 12 |
| D020920 | Dyssomnias |