SleepSHAPENCT03603041
Nutrition, Body Composition, and Sleep
A study testing Whey protein and Omega-3 fatty acids in people with Sleep and Body Composition, run by University of Arkansas, Fayetteville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Body Composition, Strength
- What is being tested?
- Whey protein and Omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 85 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women (12+ months following last reported menstrual cycle)
Who cannot join
- 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
Show all 10Show fewer
- habitual alcohol consumption (> 4 drinks/week)
- medication impacting appetite or metabolism
- Lipid or blood pressure lowering medication
- Hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
Official title: The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women
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
- Being tested
- Whey protein, Omega-3 fatty acids
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Participants in the protein arms will receive whey protein daily for 16 weeks.
Omega-3 fatty acidsDietary supplement
Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Whey protein |
| Omega-3 Fatty Acids (O3FA) | Experimental | Participants will receive O3FA supplementation daily for 16 weeks. Receives: Dietary Supplement: Omega-3 fatty acids |
| Whey Protein and O3FA | Experimental | Participants will receive protein and O3FA supplementation daily for 16 weeks. Receives: 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. Receives: Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in sleep quality from baseline (day 0) to 16 weeks.
Secondary outcomes (5)
Dietary intake
Dietary intake will be measured using 3-day, weighed food records.
Measured: Change in dietary intake from baseline (day 0) to 16 weeks.
Sleep Quantity
Sleep duration will be measured using Actigraph monitors worn on the wrist.
Measured: Change in sleep quantity from baseline (day 0) to 16 weeks.
Body composition
Body composition will be measured using dual x-ray absorptiometry (DEXA).
Measured: On day 1 and day 112 (final day of 16-week intervention) of study.
Resting energy expenditure (REE)
REE will be measured using indirect calorimetry.
Measured: On day 1 and day 112 (final day of 16-week intervention) of study.
Orexin
Intravenous blood samples will be collected and orexin measured using a commercial kit.
Measured: On day 1 and day 112 (final day of 16-week intervention) of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start16 Jul 2018
- Primary completion31 Jul 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie I Baum, Phd, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603041
- Sponsor's protocol ID
- UArkansasFayetteville
- Acronym
- SHAPE
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein and Omega-3 Fatty Acid Supplementation on Body Composition, Sleep, Cardiometabolic Health and Strength in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03603041
- Acronym / sponsor ID
- SHAPE / UArkansasFayetteville
- Conditions
- Sleep, Body Composition, Strength, Insulin Sensitivity, Energy Expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –These participants will maintain their daily food and exercise routine and will receive no intervention. |
| Whey Protein Supplementation | Experimental | Dietary Supplement: Whey proteinParticipants will receive protein supplementation daily for 16 weeks. |
| Omega-3 Fatty Acids (O3FA) | Experimental | Dietary Supplement: Omega-3 fatty acidsParticipants will receive O3FA supplementation daily for 16 weeks. |
| Whey Protein and O3FA | Experimental | Dietary Supplement: Whey protein, Dietary Supplement: Omega-3 fatty acidsParticipants will receive protein and O3FA supplementation daily for 16 weeks. |
| Whey Protein and Placebo Fat Source | Placebo comparator | Dietary Supplement: Whey proteinParticipants will receive protein and placebo fat source supplementation daily for 16 weeks. |
Who may qualify
- Ages
- Up to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women (12+ months following last reported menstrual cycle)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey proteinParticipants in the protein arms will receive whey protein daily for 16 weeks. | Dietary supplement | Whey Protein Supplementation, Whey Protein and O3FA, Whey Protein and Placebo Fat Source |
| Omega-3 fatty acidsParticipants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks. | Dietary supplement | Omega-3 Fatty Acids (O3FA), Whey Protein and O3FA |
Primary outcome
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.
5 secondary outcomes
Dietary intake
Time frame: Change in dietary intake from baseline (day 0) to 16 weeks.
Sleep Quantity
Time frame: Change in sleep quantity from baseline (day 0) to 16 weeks.
Body composition
Time frame: On day 1 and day 112 (final day of 16-week intervention) of study.
Resting energy expenditure (REE)
Time frame: On day 1 and day 112 (final day of 16-week intervention) of study.
Orexin
Time frame: On day 1 and day 112 (final day of 16-week intervention) of study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie I Baum, Phd principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and Omega-3 fatty acids in people with Sleep and Body Composition, run by University of Arkansas, Fayetteville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Change in sleep quality from baseline (day 0) to 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.