Improving Dietary Protein Intake in Adults

Healthy Clinical Trial

Official title:

Improving Dietary Protein Intake in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378556
• Other study ID #: 1151456-1
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: May 2020
• Source: Florida Atlantic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Nutritional coaching
Participants were provided with nutrition education and a per-meal protein prescription followed by 9 weeks of nutritional coaching.

Locations

Country	Name	City	State
United States	Florida Atlantic University	Boca Raton	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Atlantic University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Protein intake	Protein intake (g/kg/body weight) per day	Change from baseline to 10 weeks
Secondary	Change in Grip strength	Grip strength measured using dynamometer	Change from baseline to 10 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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