Sleep Problems, Insomnia
Conditions
Keywords
Montmorency, cherry, flavonoids, sleep quality
Brief summary
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.
Detailed description
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.
Interventions
OTHERTart Cherry Juice
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.
OTHERPlacebo juice
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.
Sponsors
Courtney Millar
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men and women aged ≥65 years * Self-reporting insomnia (e.g., trouble sleeping approximately 3 nights a week for at least 6 months and/or an Insomnia Severity Index score ≥ 10 points) * Usual bed-time between 8:00 pm and 1:00 am
Exclusion criteria
* Unwilling to follow the study protocol * Inability to properly use the wearable device, complete smartphone-based surveys, or follow the intervention protocol * Self-report of medically diagnosed sleep disorders except insomnia (e.g., sleep apnea) * Current and consistent use of sleep aids or hypnotic prescriptions (e.g., trazadone) * Self-report of cognitive impairment, dementia, or other neurological disorder * Are on unstable medications (i.e., change within the last 3 months) for other conditions * Have an allergy to the intervention products * Self-report history of diabetes * Current alcohol (Alcohol Use Disorders Identification Test ≥4 points33,34) or drug use disorder (Drug Abuse Screening Test,35,36 DAST-10\>2 points) * Are excessive caffeine drinkers (\>5 cups of caffeinated beverages a day) * Any other reason/condition the PI and investigative team believe this intervention would be unsafe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From first contact until randomization | Number of individuals that need to be screened to be enrolled that are randomized to the intervention. |
| Attrition | From randomization until end of 12 week study | Number of individuals randomized that withdraw from the intervention after randomization and starting the intervention product. |
| Compliance | From randomization until end of 12 week study | The number of doses consumed/ the number of intended doses (%) |
| Ability to Collect Data | From enrollment to end of 12 week study | The percentage of missing data points from electronic capture data devices. |
| Practicality | Week 12 study visit | Self-reported willingness to continue the dietary regimen after study completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quantity (minutes) | From enrollment to end of 12 week study | — |
| Sleep Quality | Week 1, Week 5, Week 8, Week 12 | 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. |
| 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 | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCourtney Millar, PhD
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School
Outcome results
None listed