Menopause Related ConditionsNCT05714462
Effects of Beef Consumption on Skeletal Muscle Protein Homeostasis and Inflammatory Factors in Pre- and Postmenopausal Females
A study testing meals consisting of primarily animal protein sources and meals consisting of plant protein sources in people with Menopause Related Conditions, run by University of Arkansas at 1 site in United States.
Trial summary
This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- meals consisting of primarily animal protein sources and meals consisting of plant protein sources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 1 Apr 2025
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women ages 50-65 (absence of menstruation for at least 12 months).
- Premenopausal women ages 35-45 (presence of normal monthly menstruation for the past 12 months).
- BMI of 20.0 - 34.9 kg/m2.
- COVID-19 negative and/or asymptomatic
Who cannot join
- Any substantial musculoskeletal injuries/diseases that have limited daily activities in the past month.
- Unable to stop the use of anti-inflammatory drugs for the week prior to and during study.
- Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).
- Currently pregnant.
- Gave birth or was lactating within previous 12 months.
- Undergone gastric bypass/bariatric surgery.
Show all 13Show fewer
- Clinically significant weight gain or loss (>5% change) in the last 12 months.
- Consuming metabolism-altering drugs or medications (i.e., corticosteroids, stimulants, insulin, thyroid medication).
- Unable or unwilling to suspend anti-clotting medications including aspirin use for 5 days prior to Visit 4.
- Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.
- Unwilling to fast overnight.
- Surgical menopause.
- Having undergone hormone replacement therapy in the last 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center of Translational Research in Aging and Longevity
Little Rock, Arkansas, 72205
About this study
This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods.
Read the detailed description
A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females. A premenopausal normal/overweight group consuming beef containing study meals will also be recruited to serve as a healthy control comparison.
- Conditions
- Menopause Related Conditions
- Being tested
- meals consisting of primarily animal protein sources, meals consisting of plant protein sources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meals consisting of primarily animal protein sourcesOther
an omnivorous diet
meals consisting of plant protein sourcesOther
an herbivorous diet
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal with normal/overweight BMI that eats primarily beef as their protein source | Experimental | Not described Receives: Other: meals consisting of primarily animal protein sources |
| postmenopausal with normal/overweight BMI that eats vegetables as their protein source | Experimental | Not described Receives: Other: meals consisting of plant protein sources |
| postmenopausal with obese BMI that eats primarily beef as their protein source in study meals | Experimental | Not described Receives: Other: meals consisting of primarily animal protein sources |
| postmenopausal with obese BMI that eats vegetables as their protein source in study meals | Experimental | Not described Receives: Other: meals consisting of plant protein sources |
| premenopausal with normal/overweight BMI that eats primarily beef as their protein source | Active comparator | Not described Receives: Other: meals consisting of primarily animal protein sources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net change in muscle protein synthesis (% per day).
Change in net muscle protein synthesis between groups.
Measured: Study meals are eaten for 5 consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start28 Aug 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714462
- Sponsor's protocol ID
- 275449
- Status last verified
- May 2025
- First submitted
- 26 Jan 2023
- Last updated
- 6 May 2025
- 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 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beef Consumption on Skeletal Muscle Protein Homeostasis and Inflammatory Factors in Pre- and Postmenopausal Females
- ClinicalTrials.gov ID
- NCT05714462
- Acronym / sponsor ID
- 275449
- Conditions
- Menopause Related Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Feb 2023 (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.
This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods.
Detailed description
A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females. A premenopausal normal/overweight group consuming beef containing study meals will also be recruited to serve as a healthy control comparison.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- A randomized cross-sectional controlled trial will be conducted to quantify whole-body and muscle protein turnover and skeletal muscle inflammation following 5-days of consumption of either beef or isonitrogenous plant-based sources of protein in normal/overweight and obese post-menopausal females.
| Arm | Type | Receives |
|---|---|---|
| postmenopausal with normal/overweight BMI that eats primarily beef as their protein source | Experimental | Other: meals consisting of primarily animal protein sources |
| postmenopausal with normal/overweight BMI that eats vegetables as their protein source | Experimental | Other: meals consisting of plant protein sources |
| postmenopausal with obese BMI that eats primarily beef as their protein source in study meals | Experimental | Other: meals consisting of primarily animal protein sources |
| postmenopausal with obese BMI that eats vegetables as their protein source in study meals | Experimental | Other: meals consisting of plant protein sources |
| premenopausal with normal/overweight BMI that eats primarily beef as their protein source | Active comparator | Other: meals consisting of primarily animal protein sources |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women ages 50-65 (absence of menstruation for at least 12 months).
- Premenopausal women ages 35-45 (presence of normal monthly menstruation for the past 12 months).
- BMI of 20.0 - 34.9 kg/m2.
- COVID-19 negative and/or asymptomatic
Key exclusion criteria (13 listed)
- Any substantial musculoskeletal injuries/diseases that have limited daily activities in the past month.
- Unable to stop the use of anti-inflammatory drugs for the week prior to and during study.
- Diagnosed metabolic or hormonal disease (i.e., renal, cardiovascular, thyroid, polycystic ovary syndrome, or type I/II diabetes mellitus).
- Currently pregnant.
- Gave birth or was lactating within previous 12 months.
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 |
|---|---|---|
| meals consisting of primarily animal protein sourcesan omnivorous diet | Other | postmenopausal with normal/overweight BMI that eats primarily beef as their protein source, postmenopausal with obese BMI that eats primarily beef as their protein source in study meals, premenopausal with normal/overweight BMI that eats primarily beef as their protein source |
| meals consisting of plant protein sourcesan herbivorous diet | Other | postmenopausal with normal/overweight BMI that eats vegetables as their protein source, postmenopausal with obese BMI that eats vegetables as their protein source in study meals |
Primary outcome
Net change in muscle protein synthesis (% per day).
Time frame: Study meals are eaten for 5 consecutive days.
Change in net muscle protein synthesis between groups.
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 6 May 2025.
- Individual participant dataSharing planned: No
Related trials for Menopause Related Conditions
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingObservational study
Heart Failure in Women: Epidemiological and Prognostic Insights
Heart Failure
Recruiting
Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause
Perimenopause, Postmenopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Haelan 951 for Menopause Symptoms in Peri- and Postmenopausal Women
Menopause, Menopause Hot Flashes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing meals consisting of primarily animal protein sources and meals consisting of plant protein sources in people with Menopause Related Conditions, run by University of Arkansas 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 4 inclusion and 13 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 6 May 2025. 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. 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?
Net change in muscle protein synthesis (% per day). (time frame: Study meals are eaten for 5 consecutive days.). 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 6 May 2025.