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NCT Number: NCT04677946

Dietary Oil to Improve Sleep Quality

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.

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Key information

Conditions

Insomnia Type; Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, but is not clear if linoleic acid consumption can influence sleep quality.

The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following specific aims

Aim 1) To determine the effect of healthy cookies made with linoleic acid-rich oil on measures of sleep quality and sleep architecture in overweight adults

Aim 2) To determine the effect on plasma fatty acid composition and markers of circadian rhythm in peripheral blood mononuclear cells (PBMC) after four and eight weeks of consuming one healthy cookie per day

Aim 3) To measure the effect of healthy cookies made with LA-oil on change of lipidomic profiles of plasma and PBMC after four and eight weeks of consumption

Aim 4) To determine the feasibility of adherence to consuming 1 healthy cookie per day in place of snack for eight weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

High Linoleic Acid Healthy Cookies

Other

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

Primary outcomes

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

    Time frame: Week 0, week 4 and week 8

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

  2. Feasibility of daily healthy cookie consumption

    Time frame: Week 8

    Percent of healthy cookies consumed

  3. Changes in blood fatty acids

    Time frame: Week 0, week 4 and week 8

    Changes in linoleic acid levels in the blood

  4. Changes in markers of circadian rhythm

    Time frame: Week 0, week 4 and week 8

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

  5. Changes in blood lipidomic profiles

    Time frame: Week 0, week 4 and week 8

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

  6. Changes in activity during waking and sleeping hours using an actigraph

    Time frame: Week 0, week 4 and week 8

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

  7. Changes in sleep electroencephalography (EEG)

    Time frame: Week 0, week 4 and week 8

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

Secondary outcomes

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

    Time frame: Week 0 and week 8

    Changes in body mass index and sagittal diameter

  2. Changes in marker of glycemia

    Time frame: Week 0, week 4 and week 8

    Changes in glucose and insulin

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

    Time frame: Week 0 and week 8

    Changes in grip (hand strength) and gait (walking) speed

  4. Changes in markers of inflammation

    Time frame: Week 0, week 4 and week 8

    Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Belury, Ph.D., RD

CONTACT

[email protected]

614-292-1680

Rachel Cole, M.S., RD

CONTACT

[email protected]

614-247-8235

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Dietary Oil to Improve Sleep Quality: SNACk Study

Acronym: SNACk

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Dec 21, 2020
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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