Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03603041
Other study ID # UArkansasFayetteville
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Completed NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4