Protein and Exercise for Postmenopausal Women's Wellbeing (PROWELL)

University of Arkansas, Fayetteville

Status: Enrolling

Conditions: Postmenopausal

Treatments: Behavioral: Physical activity and resistance training; Other: Diet - higher protein

Study type: Interventional

Funder types: Other

Identifiers

NCT06849817

PROWELL - 532739

AWD-104591 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Other: Diet - higher protein

Protein (Beef) + Physical Activity

Experimental group

Description:

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.

Treatment:

Other: Diet - higher protein

Behavioral: Physical activity and resistance training