Dietary Oil to Improve Sleep Quality

NCT04677946 | Not Yet Recruiting

• 1 other identifier: 2019H0327
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to identify if healthy cookies high in linoleic acid can change sleep quality and sleep architecture, blood fatty acid composition and be consumed with high compliance after eight weeks of consumption. The hypothesis is that consumption of healthy cookies for 8 weeks will improve sleep quality, increase linoleic acid in the blood and be consumed with greater than 80% compliance.

Conditions

Insomnia Type; Sleep Disorder

Outcome Measures

Primary Outcomes (7)

• Changes in sleep quality using the Pittsburgh Sleep quality index, PROMIS Sleep questionnaire, and insomnia severity index questionnaire

  Changes in global sleep quality scores using the Pittsburgh sleep quality index PROMIS Sleep questionnaire, and insomnia severity index measurements

  Week 0, week 4 and week 8

• Feasibility of daily healthy cookie consumption

  Percent of healthy cookies consumed

  Week 8

• Changes in blood fatty acids

  Changes in linoleic acid levels in the blood

  Week 0, week 4 and week 8

• Changes in markers of circadian rhythm

  Changes in mRNA expression of genes related to circadian rhythm in peripheral blood mononuclear cells

  Week 0, week 4 and week 8

• Changes in blood lipidomic profiles

  Changes in linoleic acid oxylipins in plasma and cardiolipin in peripheral blood mononuclear cells

  Week 0, week 4 and week 8

• Changes in activity during waking and sleeping hours using an actigraph

  Changes in activity during waking and sleeping hours each day will be measured using actigraphy

  Week 0, week 4 and week 8

• Changes in sleep electroencephalography (EEG)

  Changes in sleep EEG will be measured to determine sleep efficiency, arousal index, total sleep time

  Week 0, week 4 and week 8

Secondary Outcomes (4)

• Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness

  Week 0 and week 8

• Changes in marker of glycemia

  Week 0, week 4 and week 8

• Changes in markers of muscle function using gait speed and grip strength

  Week 0 and week 8

• Changes in markers of inflammation

  Week 0, week 4 and week 8

Study Arms (1)

Healthy Cookie Group

EXPERIMENTAL

All participants in the study

Other: High Linoleic Acid Healthy Cookies

Interventions

High Linoleic Acid Healthy Cookies OTHER

High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks

Healthy Cookie Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight (BMI ≥25 and \<38)
• Nonsmoker
• Insomnia severity index score ≥8

You may not qualify if:

• Current or previous diagnosis of diabetes, heart (including stroke or heart attack), kidney, liver or circulatory diseases and/or current treatment for cancer
• Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
• Food Allergy or Intolerance
• Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated
• Use of medications where consuming the healthy cookies would be contraindicated
• Usage of sleep aid (prescription medication(s)) for insomnia
• Pregnancy

Sponsors & Collaborators

• Ohio State University: lead

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Martha Belury, Ph.D., RD

CONTACT

614-292-1680; belury.1@osu.edu

Rachel Cole, M.S., RD

CONTACT

614-247-8235; cole.311@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: December 21, 2020
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-12