Dietary Oil to Improve Sleep Quality (SNACk)
Primary Purpose
Insomnia Type; Sleep Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Linoleic Acid Healthy Cookies
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Type; Sleep Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Cookie Group
Arm Description
All participants in the study
Outcomes
Primary Outcome Measures
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
Feasibility of daily healthy cookie consumption
Percent of healthy cookies consumed
Changes in blood fatty acids
Changes in linoleic acid levels in the blood
Changes in markers of circadian rhythm
Changes in mRNA expression of genes related to circadian rhythm in peripheral blood mononuclear cells
Changes in blood lipidomic profiles
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
Changes in activity during waking and sleeping hours each day will be measured using actigraphy
Changes in sleep electroencephalography (EEG)
Changes in sleep EEG will be measured to determine sleep efficiency, arousal index, total sleep time
Secondary Outcome Measures
Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness
Changes in body mass index and sagittal diameter
Changes in marker of glycemia
Changes in glucose and insulin
Changes in markers of muscle function using gait speed and grip strength
Changes in grip (hand strength) and gait (walking) speed
Changes in markers of inflammation
Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein
Full Information
NCT ID
NCT04677946
First Posted
September 18, 2020
Last Updated
March 13, 2023
Sponsor
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT04677946
Brief Title
Dietary Oil to Improve Sleep Quality
Acronym
SNACk
Official Title
Dietary Oil to Improve Sleep Quality: SNACk Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Type; Sleep Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Cookie Group
Arm Type
Experimental
Arm Description
All participants in the study
Intervention Type
Other
Intervention Name(s)
High Linoleic Acid Healthy Cookies
Intervention Description
High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks
Primary Outcome Measure Information:
Title
Changes in sleep quality using the Pittsburgh Sleep quality index, PROMIS Sleep questionnaire, and insomnia severity index questionnaire
Description
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 8
Title
Feasibility of daily healthy cookie consumption
Description
Percent of healthy cookies consumed
Time Frame
Week 8
Title
Changes in blood fatty acids
Description
Changes in linoleic acid levels in the blood
Time Frame
Week 0, week 4 and week 8
Title
Changes in markers of circadian rhythm
Description
Changes in mRNA expression of genes related to circadian rhythm in peripheral blood mononuclear cells
Time Frame
Week 0, week 4 and week 8
Title
Changes in blood lipidomic profiles
Description
Changes in linoleic acid oxylipins in plasma and cardiolipin in peripheral blood mononuclear cells
Time Frame
Week 0, week 4 and week 8
Title
Changes in activity during waking and sleeping hours using an actigraph
Description
Changes in activity during waking and sleeping hours each day will be measured using actigraphy
Time Frame
Week 0, week 4 and week 8
Title
Changes in sleep electroencephalography (EEG)
Description
Changes in sleep EEG will be measured to determine sleep efficiency, arousal index, total sleep time
Time Frame
Week 0, week 4 and week 8
Secondary Outcome Measure Information:
Title
Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness
Description
Changes in body mass index and sagittal diameter
Time Frame
Week 0 and week 8
Title
Changes in marker of glycemia
Description
Changes in glucose and insulin
Time Frame
Week 0, week 4 and week 8
Title
Changes in markers of muscle function using gait speed and grip strength
Description
Changes in grip (hand strength) and gait (walking) speed
Time Frame
Week 0 and week 8
Title
Changes in markers of inflammation
Description
Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein
Time Frame
Week 0, week 4 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Belury, Ph.D., RD
Phone
614-292-1680
Email
belury.1@osu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Cole, M.S., RD
Phone
614-247-8235
Email
cole.311@osu.edu
12. IPD Sharing Statement
Learn more about this trial
Dietary Oil to Improve Sleep Quality
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