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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | These participants will maintain their daily food and exercise routine and will receive no intervention. | |
| Whey Protein Supplementation | Experimental | Participants will receive protein supplementation daily for 16 weeks. |
|
| Omega-3 Fatty Acids (O3FA) | Experimental | Participants will receive O3FA supplementation daily for 16 weeks. |
|
| Whey Protein and O3FA | Experimental | Participants will receive protein and O3FA supplementation daily for 16 weeks. |
|
| Whey Protein and Placebo Fat Source | Placebo Comparator | Participants will receive protein and placebo fat source supplementation daily for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | Participants in the protein arms will receive whey protein daily for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | Dietary intake will be measured using 3-day, weighed food records. | Change in dietary intake from baseline (day 0) to 16 weeks. |
| Sleep Quantity | Sleep duration will be measured using Actigraph monitors worn on the wrist. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
- Postmenopausal women (12+ months following last reported menstrual cycle)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie I Baum, Phd | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Fayetteville | Arkansas | 72704 | United States |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Omega-3 fatty acids | Dietary Supplement | Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks. |
|
| Change in sleep quantity from baseline (day 0) to 16 weeks. |
| 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. |
| 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. |
| 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. |
| Change in sleep quality from baseline (day 0) to 16 weeks. |
| 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. |
| 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. |
| 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. |
| 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. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |