Addressing Sleep Problems in Older Adults

NCT02593981 | Withdrawn

• 1 other identifier: 15-006031
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

sleep; fruit; honey; geriatric

Outcome Measures

Primary Outcomes (1)

• PSQI score

  Pittsburgh Sleep Quality Index (PSQI):

  28 days

Study Arms (2)

Fruit/Honey Drink

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo (2 canisters) will be taken orally twice a day. Subjects will consume the placebo drink on days 1 through 28.

Dietary Supplement: Placebo

Interventions

Fruit/Honey drink DIETARY_SUPPLEMENT

2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days

Fruit/Honey Drink

Placebo DIETARY_SUPPLEMENT

2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years old at the time of study registration.
• Individual describes trouble either falling asleep or staying asleep at study entry.
• Willing to participate in all aspects of the study.
• Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
• 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).

You may not qualify if:

• Allergic to kiwifruit, cherries, honey, apples, or bananas.
• Hospitalized or living in a care facility at the time of enrollment.
• Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
• Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
• Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
• Allergy or intolerance of milk products.
• Women of child bearing potential.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Brent Bauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: March 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)