Dietary Oil to Improve Sleep Quality
ConditionInsomnia Type; Sleep Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Overweight (BMI ≥25 and <38)
Nonsmoker
Insomnia severity index score ≥8
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
High Linoleic Acid Healthy Cookies
Other interventionHigh Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Healthy Cookie GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Week 0, week 4 and week 82
Feasibility of daily healthy cookie consumption
Percent of healthy cookies consumed
Time frame
Week 83
Changes in blood fatty acids
Changes in linoleic acid levels in the blood
Time frame
Week 0, week 4 and week 84
Changes in markers of circadian rhythm
Changes in mRNA expression of genes related to circadian rhythm in peripheral blood mononuclear cells
Time frame
Week 0, week 4 and week 8Secondary outcomes
1
Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness
Changes in body mass index and sagittal diameter
Time frame
Week 0 and week 82
Changes in marker of glycemia
Changes in glucose and insulin
Time frame
Week 0, week 4 and week 83
Changes in markers of muscle function using gait speed and grip strength
Changes in grip (hand strength) and gait (walking) speed
Time frame
Week 0 and week 84
Changes in markers of inflammation
Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein
Time frame
Week 0, week 4 and week 8Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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