Dietary Oil to Improve Sleep Quality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Linoleic Acid Healthy Cookies.
- Who it may be relevant to
- Registry conditions: Insomnia Type; Sleep Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dietary Oil to Improve Sleep Quality: SNACk Study
Overview
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
Interventions
- Other High Linoleic Acid Healthy Cookies
High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks
Primary outcome measures
- Changes in sleep quality using the Pittsburgh Sleep quality index, PROMIS Sleep questionnaire, and insomnia severity index questionnaire [Time frame: Week 0, week 4 and week 8]
- Feasibility of daily healthy cookie consumption [Time frame: Week 8]
- Changes in blood fatty acids [Time frame: Week 0, week 4 and week 8]
- Changes in markers of circadian rhythm [Time frame: Week 0, week 4 and week 8]
- Changes in blood lipidomic profiles [Time frame: Week 0, week 4 and week 8]
- Changes in activity during waking and sleeping hours using an actigraph [Time frame: Week 0, week 4 and week 8]
- Changes in sleep electroencephalography (EEG) [Time frame: Week 0, week 4 and week 8]
Secondary outcome measures (4)
- Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness [Time frame: Week 0 and week 8]
- Changes in marker of glycemia [Time frame: Week 0, week 4 and week 8]
- Changes in markers of muscle function using gait speed and grip strength [Time frame: Week 0 and week 8]
- Changes in markers of inflammation [Time frame: Week 0, week 4 and week 8]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04677946 · 2019H0327