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Completed

NCT Number: NCT04378556

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.

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Key information

Conditions

Healthy

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Atlantic University

Boca Raton, Florida, 33431, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Coaching

Behavioral

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

Primary outcomes

  1. Change in Protein intake

    Time frame: Change from baseline to 10 weeks

    Protein intake (g/kg/body weight) per day

Secondary outcomes

  1. Change in Grip strength

    Time frame: Change from baseline to 10 weeks

    Grip strength measured using dynamometer

  2. Change in Timed Up and Go Test

    Time frame: Change from baseline to 10 weeks

    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.

  3. Change in 3 meter walk

    Time frame: Change from baseline to 10 weeks

    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

  4. Change in 5-Chair Rise Stand Test

    Time frame: Change from baseline to 10 weeks

    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.

  5. Change in Short Performance Physical Battery Score

    Time frame: Change from baseline to 10 weeks

    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

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 7, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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