Nutrition, Body Composition, and Sleep

Sleep Clinical Trial

— SHAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603041
• Other study ID #: UArkansasFayetteville
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: February 2021
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Body Composition
• Energy Expenditure
• Insulin Resistance
• Insulin Sensitivity
• Sleep
• Strength

Intervention

Dietary Supplement:
• Whey protein
Participants in the protein arms will receive whey protein daily for 16 weeks.
• Omega-3 fatty acids
Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

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.