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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in sleep quality using the Pittsburgh Sleep quality index, PROMIS Sleep questionnaire, and insomnia severity index questionnaire
Timeframe: Week 0, week 4 and week 8
2
Feasibility of daily healthy cookie consumption
Timeframe: Week 8
3
Changes in blood fatty acids
Timeframe: Week 0, week 4 and week 8
4
Changes in markers of circadian rhythm
Timeframe: Week 0, week 4 and week 8
5
Changes in blood lipidomic profiles
Timeframe: Week 0, week 4 and week 8
6
Changes in activity during waking and sleeping hours using an actigraph