PostmenopausalPROWELLNCT06849817
Protein and Exercise for Postmenopausal Women's Wellbeing
A study testing Diet - higher protein and Physical activity and resistance training in people with Postmenopausal, run by University of Arkansas, Fayetteville at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal
- What is being tested?
- Diet - higher protein and Physical activity and resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women aged 50 years and older (at least 12 months since last menstrual cycle)
- Participant in physical activity (e.g., 2-4 bouts of physical activity per week (i.e., activities such as brisk walking, yoga, hiking, cycling, gardening, etc.)) -Participants taking hormone replacement therapy (HRT; at least 6 months on HRT), statins, and antihypertensive medications will be allowed to participate.
Who cannot join
- Food allergies
- Dietary restrictions (e.g., vegan, vegetarian, lactose intolerance, etc.)
- Diet-related conditions that would prevent them from consuming a higher protein dietary intake (e.g., impaired liver function, kidney disease)
- Participants consuming more than 0.8 g protein/kg/body weight per day (determined by 24-hour dietary recall)
- Underweight (BMI < 18.5)
- Taking nutritional supplements
Show all 13Show fewer
- Currently smoking or vaping
- Use marijuana
- Drink more than 4 alcoholic beverages a week
- Take medications that may interfere with the primary outcomes of the dietary intervention (e.g., antidepressants, sleep medication, etc.)
- Sleep apnea
- Pittsburgh Sleep Quality Index (PSQI) global score >5 via or sleep > 7 hours a night
- Pre-existing health conditions (e.g., diabetes (type I or II), cancer, Parkinson's Disease, Multiple Sclerosis) or conditions that would prevent them from fully participating in all aspects of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Samuel Attu, MS contact
United States2 sites, 2 recruiting
- Recruiting
Don tyson Center for Agricultural Sciencers
Fayetteville, Arkansas, 72704
Jean-Francios Meullenet, PhD, 479-575 ext. 479-502-9801, jfmeull@uark.edu
Jamie Baum
- Recruiting
University of Arkansas
Fayetteville, Arkansas, 72704
Jamie Baum, PhD, 479-575-4474, baum@uark.edu
Ro Windwalker, 479-575-2208, irb@uark.edu
About this study
Official title: PRO-WELL: Protein and Exercise for Postmenopausal Women's Wellbeing
The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are:
- Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women?
- What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise?
Read more
Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training.
Participants will:
- Consume a higher protein diet for 16 weeks
- Participate in an at-home resistance training for 16 weeks
- Keep a diary of their food intake, sleep habits, and mood
- Have health assessments every 4 weeks
- Conditions
- Postmenopausal
- Being tested
- Diet - higher protein, Physical activity and resistance training
- Keywords
- Postmenopausal, Protein, Mood, Sleep, Wellbeing, Body composition, Amino acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet - higher proteinOther
Beef consumption 7 times per week (1 serving per day; 25 grams protein per serving (~100 grams beef) as part of a higher protein diet (1.6 g protein/kg body weight)
Physical activity and resistance trainingBehavioural
150 minutes of physical activity including strength training 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants are free-living and are asked to follow their typical dietary pattern and physical activity pattern. Maintain protein consumption at 0.8 g protein /kg body weight or less and limit red meat consumption for 16 weeks. |
| Protein (Beef) | Experimental | Participants will asked to consume beef 7 times per week (1 serving per day; 25 grams protein per serving (~100 grams beef) as part of a higher protein diet (1.6 g protein/kg body weight). Receives: Other: Diet - higher protein |
| Protein (Beef) + Physical Activity | Experimental | Participants will be asked to consume beef 7 times per week (1 serving per day; 25 grams protein per serving (~100 grams beef to yield 25 grams of protein)) as part of a higher protein diet (1.6 g protein/kg body weight) in combination with 150 minutes of physical activity including strength training 3 times per week. Receives: Other: Diet - higher protein; Behavioral: Physical activity and resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality and Duration
Sleep quality and duration will be assessed objectively via an ActiGraph triaxial wrist accelerometer GT9X Link (ActiGraph, LLC, Pensacola, FL, USA), a validated method of sleep assessment. Each participant will wear an ActiGraph monitor on the non-dominant wrist for 24 hours/day for seven days (except when bathing or involved in water activities) prior to the start of the intervention and every four weeks throughout the intervention. Accelerometers will be fitted securely on each participant's wrist. Participants will receive sleep diaries to define "time in bed" and "time out of bed." The indicated "start" and "end" points will be used to define a sleep region to be analyzed within the ActiGraph software. Sleep outcomes will be calculated based on epoch-to-epoch sleep/wake algorithms within the defined sleep period. Data will be processed by using the ActiLife Version 6.9.2 software (Pensacola, FL, USA) and sleep will be scored via the Cole-Kripke algorithm. The following
Measured: 16 weeks
Mood
The Profile of Mood States (POMS) questionnaire will be used to assess mood. POMS consists of 65 questions containing a one-word adjective of mood to measure and identify six affective states. The six identifiable mood/affective states are tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue/-inertia, and confusion-bewilderment. Participants will be instructed to define their mood on a 5-point Likert scale ranging from 0 to 4. The numbers refer to the following descriptive phrases: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a bit, 4 = Extremely. Prior to the start of the questionnaire each participant will read the following directions: Describe how you have been feeling during the past week including today by circling the number that best describes your present mood with 0 indicating "Not at all," and 4 indicating "Extremely".
Measured: 16 weeks
Qualify of Life Assessment
Quality of life assessment (QoL) will be measured using the SF-36 questionnaire. The SF-36 relies on participant self-reporting and measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores are converted to a 0-100-point scale; domain scores are derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QoL.
Measured: 16 weeks
Secondary outcomes (7)
Height
Height will be measured to the nearest 0.01 cm using a standard stadiometer.
Measured: 16 weeks
Dietary intake
Dietary intake will be measured using 3-day, weighed food records.
Measured: 16 weeks
Fat mass
Fat mass will be measured using dual x-ray absorptiometry.
Measured: 16 weeks
Plasma amino acids
Plasma amino acid profiles will be measured in the fasted state.
Measured: 16 weeks.
Fat-free mass
Fat-free mass will be measured using dual x-ray absorptiometry.
Measured: 16 weeks
Bone mineral density
Bone mineral density will be measured using dual x-ray absorptiometry.
Measured: 16 weeks
Weight
Body weight will be measured to the nearest 0.05 kg using a calibrated scale in the fasted state.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
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 Baum, Principal investigator, University of Arkansas System Division of Agriculture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849817
- Sponsor's protocol ID
- PROWELL - 532739
- Other IDs
- AWD-104591
- Acronym
- PROWELL
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are planning on sharing IPD but need approval of the plan by the University.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRO-WELL: Protein and Exercise for Postmenopausal Women's Wellbeing
- ClinicalTrials.gov ID
- NCT06849817
- Acronym / sponsor ID
- PROWELL / PROWELL - 532739
- Conditions
- Postmenopausal
- Keywords
- Postmenopausal, Protein, Mood, Sleep, Wellbeing, Body composition, Amino acids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Feb 2025 (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 goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are:
- Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women?
- What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise?
Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training.
Participants will:
- Consume a higher protein diet for 16 weeks
- Participate in an at-home resistance training for 16 weeks
- Keep a diary of their food intake, sleep habits, and mood
- Have health assessments every 4 weeks
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants are free-living and are asked to follow their typical dietary pattern and physical activity pattern. Maintain protein consumption at 0.8 g protein /kg body weight or less and limit red meat consumption for 16 weeks. |
| Protein (Beef) | Experimental | Other: Diet - higher proteinParticipants will asked to consume beef 7 times per week (1 serving per day; 25 grams protein per serving (~100 grams beef) as part of a higher protein diet (1.6 g protein/kg body weight). |
| Protein (Beef) + Physical Activity | Experimental | Other: Diet - higher protein, Behavioral: Physical activity and resistance trainingParticipants will be asked to consume beef 7 times per week (1 serving per day; 25 grams protein per serving (~100 grams beef to yield 25 grams of protein)) as part of a higher protein diet (1.6 g protein/kg body weight) in combination with 150 minutes of physical activity including strength training 3 times per week. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women aged 50 years and older (at least 12 months since last menstrual cycle)
- Participant in physical activity (e.g., 2-4 bouts of physical activity per week (i.e., activities such as brisk walking, yoga, hiking, cycling, gardening, etc.)) -Participants taking hormone replacement therapy (HRT; at least 6 months on HRT), statins, and antihypertensive medications will be allowed to participate.
Key exclusion criteria (13 listed)
- Food allergies
- Dietary restrictions (e.g., vegan, vegetarian, lactose intolerance, etc.)
- Diet-related conditions that would prevent them from consuming a higher protein dietary intake (e.g., impaired liver function, kidney disease)
- Participants consuming more than 0.8 g protein/kg/body weight per day (determined by 24-hour dietary recall)
- Underweight (BMI < 18.5)
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 |
|---|---|---|
| Diet - higher proteinBeef consumption 7 times per week (1 serving per day; 25 grams protein per serving (~100 grams beef) as part of a higher protein diet (1.6 g protein/kg body weight) | Other | Protein (Beef), Protein (Beef) + Physical Activity |
| Physical activity and resistance training150 minutes of physical activity including strength training 3 times per week | Behavioural | Protein (Beef) + Physical Activity |
Primary outcome
Sleep Quality and Duration
Time frame: 16 weeks
Sleep quality and duration will be assessed objectively via an ActiGraph triaxial wrist accelerometer GT9X Link (ActiGraph, LLC, Pensacola, FL, USA), a validated method of sleep assessment. Each participant will wear an ActiGraph monitor on the non-dominant wrist for 24 hours/day for seven days (except when bathing or involved in water activities) prior to the start of the intervention and every four weeks throughout the intervention. Accelerometers will be fitted securely on each participant's wrist. Participants will receive sleep diaries to define "time in bed" and "time out of bed." The indicated "start" and "end" points will be used to define a sleep region to be analyzed within the ActiGraph software. Sleep outcomes will be calculated based on epoch-to-epoch sleep/wake algorithms within the defined sleep period. Data will be processed by using the ActiLife Version 6.9.2 software (Pensacola, FL, USA) and sleep will be scored via the Cole-Kripke algorithm. The following
Mood
Time frame: 16 weeks
The Profile of Mood States (POMS) questionnaire will be used to assess mood. POMS consists of 65 questions containing a one-word adjective of mood to measure and identify six affective states. The six identifiable mood/affective states are tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue/-inertia, and confusion-bewilderment. Participants will be instructed to define their mood on a 5-point Likert scale ranging from 0 to 4. The numbers refer to the following descriptive phrases: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a bit, 4 = Extremely. Prior to the start of the questionnaire each participant will read the following directions: Describe how you have been feeling during the past week including today by circling the number that best describes your present mood with 0 indicating "Not at all," and 4 indicating "Extremely".
Qualify of Life Assessment
Time frame: 16 weeks
Quality of life assessment (QoL) will be measured using the SF-36 questionnaire. The SF-36 relies on participant self-reporting and measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health). Item scores are converted to a 0-100-point scale; domain scores are derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each. Higher values are indicative of better QoL.
7 secondary outcomes
Height
Time frame: 16 weeks
Dietary intake
Time frame: 16 weeks
Fat mass
Time frame: 16 weeks
Plasma amino acids
Time frame: 16 weeks.
Fat-free mass
Time frame: 16 weeks
Bone mineral density
Time frame: 16 weeks
Weight
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided. We are planning on sharing IPD but need approval of the plan by the University.
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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.
Samuel Attu, MS contact
Jamie Baum principal investigator
University of Arkansas System Division of Agriculture
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet - higher protein and Physical activity and resistance training in people with Postmenopausal, run by University of Arkansas, Fayetteville at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Baum, PhD (479-575-4474, baum@uark.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality and Duration (time frame: 16 weeks). The study lists 3 primary outcomes in all. 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 27 Feb 2025.