NCT02069314

Brief Summary

This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
Last Updated

February 24, 2014

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

February 12, 2014

Last Update Submit

February 19, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dietary protein effects on muscle energy use

    gross mechanical efficiency of muscle, consuming high and low protein supplements

    participants will be measured over an average of 26 days

Secondary Outcomes (1)

  • Effect of protein supplements on food intake

    participants will be measured over an average of 26 days

Study Arms (2)

Whey protein supplementation

EXPERIMENTAL

50 grams of whey blended into frozen drink

Dietary Supplement: Whey protein supplementation

Carbohydrate supplementation

EXPERIMENTAL

50 grams of polycose blended into frozen drink

Dietary Supplement: Carbohydrate (polycose) supplementation

Interventions

subjects are asked to consume a smoothie with whey protein added

Whey protein supplementation

Subjects are asked to consume a beverage with polycose added

Carbohydrate supplementation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and older

You may not qualify if:

  • Diabetic
  • Acute symptoms of cardiovascular disease or congestive heart failure
  • uncontrolled hypertension
  • supplemental oxygen consumption at rest or during exercise
  • lactose intolerance
  • inability to ride a stationary cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

CarbohydratesGlucansDietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Wayne W Campbell, Ph.D.

    Purdue University Dept of Nutrition Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Nutrition Science

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 24, 2014

Study Start

May 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 24, 2014

Record last verified: 2013-05

Locations