NCT04378556

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

April 27, 2020

Last Update Submit

May 4, 2020

Conditions

Healthy

Keywords

Protein intakeCoachingStrength

Outcome Measures

Primary Outcomes (1)

  • Change in Protein intake

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

    Change from baseline to 10 weeks

Secondary Outcomes (5)

  • Change in Grip strength

    Change from baseline to 10 weeks

  • Change in Timed Up and Go Test

    Change from baseline to 10 weeks

  • Change in 3 meter walk

    Change from baseline to 10 weeks

  • Change in 5-Chair Rise Stand Test

    Change from baseline to 10 weeks

  • Change in Short Performance Physical Battery Score

    Change from baseline to 10 weeks

Study Arms (1)

Nutrition

OTHER

All participants received diet coaching, nutrition education and a per-meal protein prescription.

Behavioral: Nutritional coaching

Interventions

Nutritional coachingBEHAVIORAL

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

Nutrition

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Repeated measures design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 7, 2020

Study Start

June 4, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)