Sleep Clinical Trial
— SHAPEOfficial title:
The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women
Verified date | February 2021 |
Source | University of Arkansas, Fayetteville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the research is to determine if protein and omega-3 fatty acid supplementation improve sleep, improve body composition, and improve markers of metabolic health in postmenopausal women.
Status | Completed |
Enrollment | 45 |
Est. completion date | September 15, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A to 85 Years |
Eligibility | Inclusion Criteria: - Postmenopausal women (12+ months following last reported menstrual cycle) Exclusion Criteria: - food allergies - diet restrictions - do not habitually eat breakfast - picky eaters\regularly consume protein or omega-3 related supplements - consume omega-3 fatty acid rich fish (tuna, salmon, etc.) greater than two times per month -have any other diet-related conditions that would prevent them from consuming whey protein supplements and/or omega-3 fatty acid supplements - smoking - habitual alcohol consumption (> 4 drinks/week) - medication impacting appetite or metabolism - Lipid or blood pressure lowering medication - Hormone replacement therapy |
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas | Fayetteville | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas, Fayetteville |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mood | Mood will be assessed using the Profile of Mood States (POMS) questionnaire. The POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" to "extremely" is used to assess participant mood states. | Change in sleep quality from baseline (day 0) to 16 weeks. | |
Other | Strength | Strength will be assessed using a standard hand-grip dynamometer . | On day 1 and day 112 (final day of 16-week intervention) of study. | |
Other | Glucose | Intravenous blood samples will be collected and glucose measured using a commercial kit. | On day 1 and day 112 (final day of 16-week intervention) of study. | |
Other | Insulin | Intravenous blood samples will be collected and insulin measured using a commercial kit. | On day 1 and day 112 (final day of 16-week intervention) of study. | |
Other | Blood lipids | Intravenous blood samples will be collected and blood lipids measured using a commercial kit. | On day 1 and day 112 (final day of 16-week intervention) of study. | |
Primary | Sleep Quality | Pittsburgh Sleep Quality Index (PSQI) will assess sleep quality and disturbance. This is a elf-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | Change in sleep quality from baseline (day 0) to 16 weeks. | |
Secondary | Dietary intake | Dietary intake will be measured using 3-day, weighed food records. | Change in dietary intake from baseline (day 0) to 16 weeks. | |
Secondary | Sleep Quantity | Sleep duration will be measured using Actigraph monitors worn on the wrist. | Change in sleep quantity from baseline (day 0) to 16 weeks. | |
Secondary | Body composition | Body composition will be measured using dual x-ray absorptiometry (DEXA). | On day 1 and day 112 (final day of 16-week intervention) of study. | |
Secondary | Resting energy expenditure (REE) | REE will be measured using indirect calorimetry. | On day 1 and day 112 (final day of 16-week intervention) of study. | |
Secondary | Orexin | Intravenous blood samples will be collected and orexin measured using a commercial kit. | On day 1 and day 112 (final day of 16-week intervention) of study. |
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---|---|---|---|
Completed |
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