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Completed

NCT Number: NCT03603041

Nutrition, Body Composition, and Sleep

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.

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Key information

Conditions

Sleep Body Composition Energy Expenditure Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases Strength

Age range

Up to 85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

Dietary Supplement

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

Omega-3 fatty acids

Dietary Supplement

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

Primary outcomes

  1. Sleep Quality

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

    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 outcomes

  1. Dietary intake

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

    Dietary intake will be measured using 3-day, weighed food records.

  2. Sleep Quantity

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

    Sleep duration will be measured using Actigraph monitors worn on the wrist.

  3. Body composition

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

    Body composition will be measured using dual x-ray absorptiometry (DEXA).

  4. Resting energy expenditure (REE)

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

    REE will be measured using indirect calorimetry.

  5. Orexin

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

    Intravenous blood samples will be collected and orexin measured using a commercial kit.

Other outcomes

  1. Mood

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

    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.

  2. Strength

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

    Strength will be assessed using a standard hand-grip dynamometer .

  3. Glucose

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

    Intravenous blood samples will be collected and glucose measured using a commercial kit.

  4. Insulin

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

    Intravenous blood samples will be collected and insulin measured using a commercial kit.

  5. Blood lipids

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

    Intravenous blood samples will be collected and blood lipids measured using a commercial kit.

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

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

Acronym: SHAPE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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