Improving Dietary Protein Intake in Adults

A pilot, single-arm investigation used coaching, nutrition education, and a per-meal protein prescription to assess impact on protein intake, muscle strength and function in older adults.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Nutritional coaching

Detailed Description

Objective: To evaluate the effects of nutrition education, diet coaching, and a protein prescription (PP) on protein intake, and associations with muscle strength and function. Design: Prospective pretest posttest single-arm study. Setting: Urban area, East coast of South Florida. Participants: Older adults. Intervention: 10-week telephone-based diet coaching, nutrition education and a per-meal PP. Measurements: Protein and energy intakes, weight, grip strength (GS), and 5-chair-rise (5CR), timed up and go (TUG), 3-meter walk (3mW) tests at baseline and 10 weeks.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Florida Atlantic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 55 years or older,
• Community-dwelling (living independently),
• Able to provide consent,
• Able to understand and respond to questions or instructions in English,
• Have a working telephone (for coaching sessions),
• Willingness to consume protein-containing animal products
• Willingness to make changes to the diet

Exclusion Criteria:

• Self-reported information that they have been told by a medical doctor that they have kidney (renal) disease.
• Vegan dietary practices,
• Refusal to make changes to usual dietary protein intake, or a usual dietary protein intake that meets recommendations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nutrition; All participants received diet coaching, nutrition education and a per-meal protein prescription.	Behavioral: Nutritional coaching; Participants were provided with nutrition education and a per-meal protein prescription followed by 9 weeks of nutritional coaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Protein intake	Protein intake (g/kg/body weight) per day	Change from baseline to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Grip strength	Grip strength measured using dynamometer	Change from baseline to 10 weeks
Change in Timed Up and Go Test	The timed up and go test measures the time (in seconds) that it takes to stand up from a seated position in a chair, walk 3 meters away from the chair at a comfortable pace to a line on the floor, turn around, walk back, and sit back down in the chair.	Change from baseline to 10 weeks
Change in 3 meter walk	The 3-meter walk test measures the time (in seconds) that it takes to stand up from a seated position in a chair and walk 3 meters away from the chair at a comfortable pace to a line on the floor	Change from baseline to 10 weeks
Change in 5-Chair Rise Stand Test	The 5 chair rise stand test requires participants to stand up 5 times without hand assistance from a straight back chair without an armrest. The time required to complete the 5 chair rises is recorded.	Change from baseline to 10 weeks
Change in Short Performance Physical Battery Score	The Short Physical Performance Battery (SPPB) consists of timed measures of balance, 3-meter walk, and 5-chair rises. The balance portion requires participants to stand with feet next to each other, the toes of one foot next to the heel of the other foot, and heel to toe for a 10 second duration. Scores are assigned based on the number of seconds the participant can stand in the position for balance. Scores for the chair rise and 3 meter walk are based on the time taken to complete the task. The scores are totaled to arrive at the Short Performance Physical Battery Score	Change from baseline to 10 weeks

Collaborators and Investigators

• Sponsor: Florida Atlantic University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Coaching; Strength; Protein intake
• Other Study ID Numbers: 1151456-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No