SHAPE: Nutrition, Body Composition, and Sleep
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control These participants will maintain their daily food and exercise routine and will receive no intervention. |
|
| Experimental: Whey Protein Supplementation Participants will receive protein supplementation daily for 16 weeks. |
Dietary Supplement: Whey protein
Participants in the protein arms will receive whey protein daily for 16 weeks.
|
| Experimental: Omega-3 Fatty Acids (O3FA) Participants will receive O3FA supplementation daily for 16 weeks. |
Dietary Supplement: Omega-3 fatty acids
Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.
|
| Experimental: Whey Protein and O3FA Participants will receive protein and O3FA supplementation daily for 16 weeks. |
Dietary Supplement: Whey protein
Participants in the protein arms will receive whey protein daily for 16 weeks.
Dietary Supplement: Omega-3 fatty acids
Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.
|
| Placebo Comparator: Whey Protein and Placebo Fat Source Participants will receive protein and placebo fat source supplementation daily for 16 weeks. |
Dietary Supplement: Whey protein
Participants in the protein arms will receive whey protein daily for 16 weeks.
|
Outcome Measures
Primary Outcome Measures
- Sleep Quality [Change in sleep quality from baseline (day 0) to 16 weeks.]
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.
Secondary Outcome Measures
- Dietary intake [Change in dietary intake from baseline (day 0) to 16 weeks.]
Dietary intake will be measured using 3-day, weighed food records.
- Sleep Quantity [Change in sleep quantity from baseline (day 0) to 16 weeks.]
Sleep duration will be measured using Actigraph monitors worn on the wrist.
- Body composition [On day 1 and day 112 (final day of 16-week intervention) of study.]
Body composition will be measured using dual x-ray absorptiometry (DEXA).
- Resting energy expenditure (REE) [On day 1 and day 112 (final day of 16-week intervention) of study.]
REE will be measured using indirect calorimetry.
- Orexin [On day 1 and day 112 (final day of 16-week intervention) of study.]
Intravenous blood samples will be collected and orexin measured using a commercial kit.
Other Outcome Measures
- Mood [Change in sleep quality from baseline (day 0) to 16 weeks.]
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.
- Strength [On day 1 and day 112 (final day of 16-week intervention) of study.]
Strength will be assessed using a standard hand-grip dynamometer .
- Glucose [On day 1 and day 112 (final day of 16-week intervention) of study.]
Intravenous blood samples will be collected and glucose measured using a commercial kit.
- Insulin [On day 1 and day 112 (final day of 16-week intervention) of study.]
Intravenous blood samples will be collected and insulin measured using a commercial kit.
- Blood lipids [On day 1 and day 112 (final day of 16-week intervention) of study.]
Intravenous blood samples will be collected and blood lipids measured using a commercial kit.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Postmenopausal women (12+ months following last reported menstrual cycle)
Exclusion Criteria:
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food allergies
-
diet restrictions
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do not habitually eat breakfast
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picky eaters\regularly consume protein or omega-3 related supplements
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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
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smoking
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habitual alcohol consumption (> 4 drinks/week)
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medication impacting appetite or metabolism
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Lipid or blood pressure lowering medication
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Hormone replacement therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas | Fayetteville | Arkansas | United States | 72704 |
Sponsors and Collaborators
- University of Arkansas, Fayetteville
Investigators
- Principal Investigator: Jamie I Baum, Phd, University of Arkansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UArkansasFayetteville