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| ID | Type | Description | Link |
|---|---|---|---|
| AWD-104591 | Other Identifier | National Cattlemen's Beef Association |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet - higher protein | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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". | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height will be measured to the nearest 0.01 cm using a standard stadiometer. | 16 weeks |
| Dietary intake | Dietary intake will be measured using 3-day, weighed food records. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Baum, PhD | Contact | 479-575-4474 | baum@uark.edu | |
| Samuel Attu, MS | Contact | sattu@uark.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jamie Baum | University of Arkansas System Division of Agriculture | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Don tyson Center for Agricultural Sciencers | Recruiting | Fayetteville | Arkansas | 72704 | United States |
We are planning on sharing IPD but need approval of the plan by the University.
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Physical activity and resistance training | Behavioral | 150 minutes of physical activity including strength training 3 times per week |
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| 16 weeks |
| 16 weeks |
| Fat mass | Fat mass will be measured using dual x-ray absorptiometry. | 16 weeks |
| Plasma amino acids | Plasma amino acid profiles will be measured in the fasted state. | 16 weeks. |
| Fat-free mass | Fat-free mass will be measured using dual x-ray absorptiometry. | 16 weeks |
| Bone mineral density | Bone mineral density will be measured using dual x-ray absorptiometry. | 16 weeks |
| Weight | Body weight will be measured to the nearest 0.05 kg using a calibrated scale in the fasted state. | 16 weeks |
| University of Arkansas | Recruiting | Fayetteville | Arkansas | 72704 | United States |
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| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |