Nutrition, Body Composition, and Sleep (SHAPE)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Body Composition; Insulin Sensitivity; Energy Expenditure; Strength
• Intervention / Treatment: Dietary supplement: Whey protein; Dietary supplement: Omega-3 fatty acids

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • University of Arkansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2018
• Primary Completion (ACTUAL): July 31, 2020
• Study Completion (ACTUAL): September 15, 2020

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (ACTUAL): July 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: UArkansasFayetteville

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No