Dietary Oil to Improve Sleep Quality

Официальное название

Dietary Oil to Improve Sleep Quality: SNACk Study

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Changes in sleep quality using the Pittsburgh Sleep quality index, PROMIS Sleep questionnaire, and insomnia severity index questionnaire [Срок оценки: Week 0, week 4 and week 8]
• Feasibility of daily healthy cookie consumption [Срок оценки: Week 8]
• Changes in blood fatty acids [Срок оценки: Week 0, week 4 and week 8]
• Changes in markers of circadian rhythm [Срок оценки: Week 0, week 4 and week 8]
• Changes in blood lipidomic profiles [Срок оценки: Week 0, week 4 and week 8]
• Changes in activity during waking and sleeping hours using an actigraph [Срок оценки: Week 0, week 4 and week 8]
• Changes in sleep electroencephalography (EEG) [Срок оценки: Week 0, week 4 and week 8]

Вторичные конечные точки (4)

• Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness [Срок оценки: Week 0 and week 8]
• Changes in marker of glycemia [Срок оценки: Week 0, week 4 and week 8]
• Changes in markers of muscle function using gait speed and grip strength [Срок оценки: Week 0 and week 8]
• Changes in markers of inflammation [Срок оценки: Week 0, week 4 and week 8]

Критерии участия

Критерии включения

• Overweight (BMI ≥25 and <38)
• Nonsmoker
• Insomnia severity index score ≥8

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04677946 · 2019H0327

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗