Dietary Oil to Improve Sleep Quality

Study Overview
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Brief Summary
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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
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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

Official Title
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Dietary Oil to Improve Sleep Quality: SNACk Study

Conditions
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Insomnia Type; Sleep Disorder

Intervention / Treatment
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* Other: High Linoleic Acid Healthy Cookies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Cookie Group<br>All participants in the study | Other: High Linoleic Acid Healthy Cookies<br>* High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness | Changes in body mass index and sagittal diameter | Week 0 and week 8 | 
| Changes in marker of glycemia | Changes in glucose and insulin | 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 | Week 0 and week 8 | 
| Changes in markers of inflammation | Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein | Week 0, week 4 and week 8 |