Addressing Sleep Problems in Older Adults

To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Fruit/Honey drink; Dietary supplement: Placebo

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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 Comparator: Placebo; Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.	Dietary supplement: Placebo; 2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSQI score	Pittsburgh Sleep Quality Index (PSQI):	28 days

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 8, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: sleep; geriatric; honey; fruit
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 15-006031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No