Dietary Oil to Improve Sleep Quality

Insomnia Type; Sleep Disorder Clinical Trial

— SNACk  

Official title:

Dietary Oil to Improve Sleep Quality: SNACk Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04677946
• Other study ID #: 2019H0327
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2025
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Martha Belury, Ph.D., RD
• Phone: 614-292-1680
• Email: belury.1[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Type; Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• High Linoleic Acid Healthy Cookies
High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Feasibility of daily healthy cookie consumption	Percent of healthy cookies consumed	Week 8
Primary	Changes in blood fatty acids	Changes in linoleic acid levels in the blood	Week 0, week 4 and week 8
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Changes in marker of glycemia	Changes in glucose and insulin	Week 0, week 4 and week 8
Secondary	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
Secondary	Changes in markers of inflammation	Changes in interleukin 6, tumor necrosis factor receptor 2, C-reactive protein	Week 0, week 4 and week 8