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Nutrition, Body Composition, and Sleep (SHAPE)

Primary Purpose

Sleep, Body Composition, Strength

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey protein
Omega-3 fatty acids
Sponsored by
University of Arkansas, Fayetteville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Control

Whey Protein Supplementation

Omega-3 Fatty Acids (O3FA)

Whey Protein and O3FA

Whey Protein and Placebo Fat Source

Arm Description

These participants will maintain their daily food and exercise routine and will receive no intervention.

Participants will receive protein supplementation daily for 16 weeks.

Participants will receive O3FA supplementation daily for 16 weeks.

Participants will receive protein and O3FA supplementation daily for 16 weeks.

Participants will receive protein and placebo fat source supplementation daily for 16 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dietary intake
Dietary intake will be measured using 3-day, weighed food records.
Sleep Quantity
Sleep duration will be measured using Actigraph monitors worn on the wrist.
Body composition
Body composition will be measured using dual x-ray absorptiometry (DEXA).
Resting energy expenditure (REE)
REE will be measured using indirect calorimetry.
Orexin
Intravenous blood samples will be collected and orexin measured using a commercial kit.

Full Information

First Posted
July 15, 2018
Last Updated
February 3, 2021
Sponsor
University of Arkansas, Fayetteville
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1. Study Identification

Unique Protocol Identification Number
NCT03603041
Brief Title
Nutrition, Body Composition, and Sleep
Acronym
SHAPE
Official Title
The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Body Composition, Strength, Insulin Sensitivity, Energy Expenditure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
These participants will maintain their daily food and exercise routine and will receive no intervention.
Arm Title
Whey Protein Supplementation
Arm Type
Experimental
Arm Description
Participants will receive protein supplementation daily for 16 weeks.
Arm Title
Omega-3 Fatty Acids (O3FA)
Arm Type
Experimental
Arm Description
Participants will receive O3FA supplementation daily for 16 weeks.
Arm Title
Whey Protein and O3FA
Arm Type
Experimental
Arm Description
Participants will receive protein and O3FA supplementation daily for 16 weeks.
Arm Title
Whey Protein and Placebo Fat Source
Arm Type
Placebo Comparator
Arm Description
Participants will receive protein and placebo fat source supplementation daily for 16 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
Participants in the protein arms will receive whey protein daily for 16 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Intervention Description
Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.
Primary Outcome Measure Information:
Title
Sleep Quality
Description
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.
Time Frame
Change in sleep quality from baseline (day 0) to 16 weeks.
Secondary Outcome Measure Information:
Title
Dietary intake
Description
Dietary intake will be measured using 3-day, weighed food records.
Time Frame
Change in dietary intake from baseline (day 0) to 16 weeks.
Title
Sleep Quantity
Description
Sleep duration will be measured using Actigraph monitors worn on the wrist.
Time Frame
Change in sleep quantity from baseline (day 0) to 16 weeks.
Title
Body composition
Description
Body composition will be measured using dual x-ray absorptiometry (DEXA).
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.
Title
Resting energy expenditure (REE)
Description
REE will be measured using indirect calorimetry.
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.
Title
Orexin
Description
Intravenous blood samples will be collected and orexin measured using a commercial kit.
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.
Other Pre-specified Outcome Measures:
Title
Mood
Description
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.
Time Frame
Change in sleep quality from baseline (day 0) to 16 weeks.
Title
Strength
Description
Strength will be assessed using a standard hand-grip dynamometer .
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.
Title
Glucose
Description
Intravenous blood samples will be collected and glucose measured using a commercial kit.
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.
Title
Insulin
Description
Intravenous blood samples will be collected and insulin measured using a commercial kit.
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.
Title
Blood lipids
Description
Intravenous blood samples will be collected and blood lipids measured using a commercial kit.
Time Frame
On day 1 and day 112 (final day of 16-week intervention) of study.

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie I Baum, Phd
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition, Body Composition, and Sleep

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