Nutrition, Body Composition, and Sleep

Not Applicable

Completed

• Conditions: Strength; Energy Expenditure; Insulin Sensitivity; Body Composition; Sleep
• Interventions: Dietary Supplement: Whey protein; Dietary Supplement: Omega-3 fatty acids

• Registration Number: NCT03603041
• Lead Sponsor: University of Arkansas, Fayetteville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-15
• Study Start: 2018-07-16
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-07-27
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whey Protein and Placebo Fat Source	Whey protein	Participants will receive protein and placebo fat source supplementation daily for 16 weeks.
Whey Protein Supplementation	Whey protein	Participants will receive protein supplementation daily for 16 weeks.
Whey Protein and O3FA	Omega-3 fatty acids	Participants will receive protein and O3FA supplementation daily for 16 weeks.
Whey Protein and O3FA	Whey protein	Participants will receive protein and O3FA supplementation daily for 16 weeks.
Omega-3 Fatty Acids (O3FA)	Omega-3 fatty acids	Participants will receive O3FA supplementation daily for 16 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Dietary intake	Change in dietary intake from baseline (day 0) to 16 weeks.	Dietary intake will be measured using 3-day, weighed food records.
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.
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).

Trial Locations

Locations (1)

University of Arkansas; 🇺🇸 Fayetteville, Arkansas, United States