Nutrition, Body Composition, and Sleep

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women

Conditions
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Sleep, Body Composition, Strength, Insulin Sensitivity, Energy Expenditure

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>These participants will maintain their daily food and exercise routine and will receive no intervention. | |
| Experimental: Whey Protein Supplementation<br>Participants will receive protein supplementation daily for 16 weeks. | Dietary Supplement: Whey protein<br>* Participants in the protein arms will receive whey protein daily for 16 weeks.<br>|
| Experimental: Omega-3 Fatty Acids (O3FA)<br>Participants will receive O3FA supplementation daily for 16 weeks. | Dietary Supplement: Omega-3 fatty acids<br>* Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.<br>|
| Experimental: Whey Protein and O3FA<br>Participants will receive protein and O3FA supplementation daily for 16 weeks. | Dietary Supplement: Whey protein<br>* Participants in the protein arms will receive whey protein daily for 16 weeks.<br>Dietary Supplement: Omega-3 fatty acids<br>* Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.<br>|
| Placebo Comparator: Whey Protein and Placebo Fat Source<br>Participants will receive protein and placebo fat source supplementation daily for 16 weeks. | Dietary Supplement: Whey protein<br>* Participants in the protein arms will receive whey protein daily for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. |