Nutrition, Body Composition, and Sleep (SHAPE)

University of Arkansas, Fayetteville

Status: Completed

Conditions: Strength; Energy Expenditure; Insulin Sensitivity; Body Composition; Sleep

Treatments: Dietary Supplement: Omega-3 fatty acids; Dietary Supplement: Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT03603041

UArkansasFayetteville

Details and patient eligibility

About

The purpose of the research is to determine if protein and omega-3 fatty acid supplementation improve sleep, improve body composition, and improve markers of metabolic health in postmenopausal women.

Enrollment: 45 patients

Sex: Female

Ages: Under 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Postmenopausal women (12+ months following last reported menstrual cycle)

Exclusion criteria

• food allergies
• diet restrictions
• do not habitually eat breakfast
• picky eaters\regularly consume protein or omega-3 related supplements
• consume omega-3 fatty acid rich fish (tuna, salmon, etc.) greater than two times per month -have any other diet-related conditions that would prevent them from consuming whey protein supplements and/or omega-3 fatty acid supplements
• smoking
• habitual alcohol consumption (> 4 drinks/week)
• medication impacting appetite or metabolism
• Lipid or blood pressure lowering medication
• Hormone replacement therapy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 5 patient groups, including a placebo group

Control

No Intervention group

Description:

These participants will maintain their daily food and exercise routine and will receive no intervention.

Whey Protein Supplementation

Experimental group

Description:

Participants will receive protein supplementation daily for 16 weeks.

Treatment:

Dietary Supplement: Whey protein

Omega-3 Fatty Acids (O3FA)

Experimental group

Description:

Participants will receive O3FA supplementation daily for 16 weeks.

Treatment:

Dietary Supplement: Omega-3 fatty acids

Whey Protein and O3FA

Experimental group

Description:

Participants will receive protein and O3FA supplementation daily for 16 weeks.

Treatment:

Dietary Supplement: Omega-3 fatty acids

Dietary Supplement: Whey protein

Whey Protein and Placebo Fat Source

Placebo Comparator group

Description:

Participants will receive protein and placebo fat source supplementation daily for 16 weeks.

Treatment:

Dietary Supplement: Whey protein