NCT02787889

Brief Summary

The investigators determined effects of 8-week dietary protein intake in mixed meals with uneven or even consumption pattern on the metabolic outcomes of whole-body net protein synthesis and muscle protein synthesis in older participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

May 12, 2016

Last Update Submit

May 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in net protein synthesis rate

    Change from Baseline to 8 weeks

Study Arms (2)

Uneven Protein Intake Pattern

EXPERIMENTAL

Subjects consumed either dietary protein intake at 1.1g protein/kg/day over 8 weeks.Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)\] on net protein synthesis over 8 weeks.

Other: Uneven Protein intake pattern

Even Protein Intake Pattern

EXPERIMENTAL

Subjects consumed either dietary protein intake at 1.1g protein/kg/day over 8 weeks. Each participant will consume 33% of total protein consumed each meal

Other: Even Protein Intake Pattern

Interventions

Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)\] on net protein synthesis over 8 weeks.

Uneven Protein Intake Pattern

Each participant will consume 33% of total protein consumed each meal

Even Protein Intake Pattern

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, ages 50-70 years
  • BMI between 24 and 30 kg/m2

You may not qualify if:

  • Current diagnosis of diabetes
  • History of malignancy in the 6 months prior to enrollment
  • History of lactose intolerance or dairy allergy
  • History of egg allergy or intolerance
  • History of gastrointestinal bypass surgery.
  • History of a chronic inflammatory condition or other chronic disease (Lupus, HIV/AIDS, etc)
  • Subjects who do not or will not eat animal proteins
  • Subjects who cannot refrain from consuming protein or amino acid supplements during their participation in this study
  • Subjects who report regular resistance exercise (more than twice per week)
  • Hemoglobin less than 9.5 mg/dL at the screening visit
  • Platelets less than 150,000 at the screening visit
  • Concomitant use of corticosteroids (ingestion, injection or transdermal)
  • Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kim IY, Schutzler S, Schrader AM, Spencer HJ, Azhar G, Wolfe RR, Ferrando AA. Protein intake distribution pattern does not affect anabolic response, lean body mass, muscle strength or function over 8 weeks in older adults: A randomized-controlled trial. Clin Nutr. 2018 Apr;37(2):488-493. doi: 10.1016/j.clnu.2017.02.020. Epub 2017 Mar 3.

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Arny A Ferrando, Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 1, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05