Postmenopausal
Conditions
Keywords
Postmenopausal, Protein, Mood, Sleep, Wellbeing, Body composition, Amino acids
Brief 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. 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
Interventions
OTHERDiet - higher protein
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)
BEHAVIORALPhysical activity and resistance training
150 minutes of physical activity including strength training 3 times per week
Sponsors
University of Arkansas, Fayetteville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality and Duration | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma amino acids | 16 weeks. | Plasma amino acid profiles will be measured in the fasted state. |
| Fat-free mass | 16 weeks | Fat-free mass will be measured using dual x-ray absorptiometry. |
| Height | 16 weeks | Height will be measured to the nearest 0.01 cm using a standard stadiometer. |
| Weight | 16 weeks | Body weight will be measured to the nearest 0.05 kg using a calibrated scale in the fasted state. |
| Bone mineral density | 16 weeks | Bone mineral density will be measured using dual x-ray absorptiometry. |
| Dietary intake | 16 weeks | Dietary intake will be measured using 3-day, weighed food records. |
| Fat mass | 16 weeks | Fat mass will be measured using dual x-ray absorptiometry. |
Countries
United States
Contacts
Primary ContactJamie Baum, PhD
Backup ContactSamuel Attu, MS
Outcome results
None listed