Nutrition, Body Composition, and Sleep

NCT ID: NCT03603041

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-09-15

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.

Detailed Description

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Conditions

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Sleep Body Composition Strength Insulin Sensitivity Energy Expenditure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Whey Protein Supplementation

Participants will receive protein supplementation daily for 16 weeks.

Group Type EXPERIMENTAL

Whey protein

Intervention Type DIETARY_SUPPLEMENT

Participants in the protein arms will receive whey protein daily for 16 weeks.

Omega-3 Fatty Acids (O3FA)

Participants will receive O3FA supplementation daily for 16 weeks.

Group Type EXPERIMENTAL

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.

Whey Protein and O3FA

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

Group Type EXPERIMENTAL

Whey protein

Intervention Type DIETARY_SUPPLEMENT

Participants in the protein arms will receive whey protein daily for 16 weeks.

Omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.

Whey Protein and Placebo Fat Source

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

Group Type PLACEBO_COMPARATOR

Whey protein

Intervention Type DIETARY_SUPPLEMENT

Participants in the protein arms will receive whey protein daily for 16 weeks.

Interventions

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Whey protein

Participants in the protein arms will receive whey protein daily for 16 weeks.

Intervention Type DIETARY_SUPPLEMENT

Omega-3 fatty acids

Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.

Intervention Type DIETARY_SUPPLEMENT

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
Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas, Fayetteville

OTHER

Sponsor Role lead

Responsible Party

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Jamie Baum

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamie I Baum, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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UArkansasFayetteville

Identifier Type: -

Identifier Source: org_study_id

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