Insomnia Type; Sleep DisorderSNACkNCT04677946
Dietary Oil to Improve Sleep Quality
A study testing High Linoleic Acid Healthy Cookies in people with Insomnia Type; Sleep Disorder, run by Ohio State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Type; Sleep Disorder
- What is being tested?
- High Linoleic Acid Healthy Cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2027to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight (BMI ≥25 and <38)
- Nonsmoker
- Insomnia severity index score ≥8
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dietary Oil to Improve Sleep Quality: SNACk Study
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.
Read the detailed description
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
- Conditions
- Insomnia Type; Sleep Disorder
- Being tested
- High Linoleic Acid Healthy Cookies
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Linoleic Acid Healthy CookiesOther
High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Healthy Cookie Group | Experimental | All participants in the study Receives: Other: High Linoleic Acid Healthy Cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 0, week 4 and week 8
Feasibility of daily healthy cookie consumption
Percent of healthy cookies consumed
Measured: Week 8
Changes in blood fatty acids
Changes in linoleic acid levels in the blood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Changes in body mass index and sagittal diameter
Measured: Week 0 and week 8
Changes in marker of glycemia
Changes in glucose and insulin
Measured: Week 0, week 4 and week 8
Changes in markers of muscle function using gait speed and grip strength
Changes in grip (hand strength) and gait (walking) speed
Measured: Week 0 and week 8
Changes in markers of inflammation
Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein
Measured: Week 0, week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startDec 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Type; Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Belury, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677946
- Sponsor's protocol ID
- 2019H0327
- Acronym
- SNACk
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2020
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Oil to Improve Sleep Quality: SNACk Study
- ClinicalTrials.gov ID
- NCT04677946
- Acronym / sponsor ID
- SNACk / 2019H0327
- Conditions
- Insomnia Type; Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Dec 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Cookie Group | Experimental | Other: High Linoleic Acid Healthy CookiesAll participants in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight (BMI ≥25 and <38)
- Nonsmoker
- Insomnia severity index score ≥8
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Linoleic Acid Healthy CookiesHigh Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks | Other | Healthy Cookie Group |
Primary outcome
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
Feasibility of daily healthy cookie consumption
Time frame: Week 8
Percent of healthy cookies consumed
Changes in blood fatty acids
Time frame: Week 0, week 4 and week 8
Changes in linoleic acid levels in the blood
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
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
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
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
4 secondary outcomes
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 marker of glycemia
Time frame: Week 0, week 4 and week 8
Changes in markers of muscle function using gait speed and grip strength
Time frame: Week 0 and week 8
Changes in markers of inflammation
Time frame: Week 0, week 4 and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing High Linoleic Acid Healthy Cookies in people with Insomnia Type; Sleep Disorder, run by Ohio State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Belury, Ph.D., RD (614-292-1680, belury.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.