Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-03-31
2019-04-30
Brief Summary
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The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.
Detailed Description
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This trial proposes to enroll a total of 60 community based older adults. All study patients will be instructed to take the study product every day for 28 days. During which time, study subjects will return weekly to complete study visits for a total of 4 visits.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fruit/Honey Drink
Fruit/Honey Drink (2 canisters) will be taken orally twice a day. Subjects will consume the drink on days 1 through 28.
Fruit/Honey drink
2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
Placebo
Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.
Placebo
2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days
Interventions
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Fruit/Honey drink
2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
Placebo
2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days
Eligibility Criteria
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Inclusion Criteria
2. Individual describes trouble either falling asleep or staying asleep at study entry.
3. Willing to participate in all aspects of the study.
4. Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
5. Willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention).
Exclusion Criteria
2. Hospitalized or living in a care facility at the time of enrollment.
3. Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
4. Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
5. Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
6. Allergy or intolerance of milk products.
7. Women of child bearing potential.
60 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Brent A. Bauer
Principal Investigator
Principal Investigators
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Brent Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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15-006031
Identifier Type: -
Identifier Source: org_study_id