Addressing Sleep Problems in Older Adults

Not Applicable

Withdrawn

• Conditions: Sleep
• Interventions: Dietary Supplement: Fruit/Honey drink; Dietary Supplement: Placebo

• Registration Number: NCT02593981
• Lead Sponsor: Mayo Clinic

Brief Summary

As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.

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

This is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. The purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention.

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.

Study Timeline

• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Study Start: 2018-03
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-08
• Last Update Posted: 2018-12-11
• Primary Completion: 2019-02
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 60 years old at the time of study registration.
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

1. Allergic to kiwifruit, cherries, honey, apples, or bananas.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fruit/Honey Drink	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.
Placebo	Placebo	Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.

Primary Outcome Measures

Name	Time	Method
PSQI score	28 days	Pittsburgh Sleep Quality Index (PSQI):

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States