Dietary Oil to Improve Sleep Quality (SNACk)

The Ohio State University

Status: Begins enrollment in 4 months

Conditions: Insomnia Type; Sleep Disorder

Treatments: Other: High Linoleic Acid Healthy Cookies

Study type: Interventional

Funder types: Other

Identifiers

NCT04677946

2019H0327

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Healthy Cookie Group

Experimental group

Description:

All participants in the study

Treatment:

Other: High Linoleic Acid Healthy Cookies