Nutrition, Body Composition, and Sleep

NCT03603041 | Completed

• 1 other identifier: UArkansasFayetteville
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Body Composition; Strength; Insulin Sensitivity; Energy Expenditure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Dietary intake

  Change in dietary intake from baseline (day 0) to 16 weeks.

• Sleep Quantity

  Change in sleep quantity from baseline (day 0) to 16 weeks.

• Body composition

  On day 1 and day 112 (final day of 16-week intervention) of study.

• Resting energy expenditure (REE)

  On day 1 and day 112 (final day of 16-week intervention) of study.

• Orexin

  On day 1 and day 112 (final day of 16-week intervention) of study.

Other Outcomes (5)

• Mood

  Change in sleep quality from baseline (day 0) to 16 weeks.

• Strength

  On day 1 and day 112 (final day of 16-week intervention) of study.

• Glucose

  On day 1 and day 112 (final day of 16-week intervention) of study.

Study Arms (5)

Control

NO INTERVENTION

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

Whey Protein Supplementation

EXPERIMENTAL

Participants will receive protein supplementation daily for 16 weeks.

Dietary Supplement: Whey protein

Omega-3 Fatty Acids (O3FA)

EXPERIMENTAL

Participants will receive O3FA supplementation daily for 16 weeks.

Dietary Supplement: Omega-3 fatty acids

Whey Protein and O3FA

EXPERIMENTAL

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

Dietary Supplement: Whey protein; Dietary Supplement: Omega-3 fatty acids

Whey Protein and Placebo Fat Source

PLACEBO COMPARATOR

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

Dietary Supplement: Whey protein

Interventions

Whey protein DIETARY_SUPPLEMENT

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

Whey Protein Supplementation; Whey Protein and O3FA; Whey Protein and Placebo Fat Source

Omega-3 fatty acids DIETARY_SUPPLEMENT

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

Omega-3 Fatty Acids (O3FA); Whey Protein and O3FA

Eligibility Criteria

• Age: Up to 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Postmenopausal women (12+ months following last reported menstrual cycle)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Whey Proteins; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Jamie I Baum, Phd

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 27, 2018
• Study Start: July 16, 2018
• Primary Completion: July 31, 2020
• Study Completion: September 15, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)