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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
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Type; Sleep Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 18, 2020
    Last Updated
    March 13, 2023
    Sponsor
    Ohio State University
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    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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