NCT02594228

Brief Summary

A primary aim of the current proposal is to compare the effect of daily consumption of healthy lean protein as either whey protein (2 meals per day) or whole food (25% of total daily caloric intake) consumed as 6 small meals throughout the day, one of which is consumed immediately following exercise training (within 30 min) and another 2 hours prior to going to bed at night, over a 16 week period on muscle and fat mass, cardiovascular health, aerobic fitness, glucose, insulin, blood lipids, heart rate and muscle strength in overweight men and women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

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

December 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

October 29, 2015

Last Update Submit

October 30, 2015

Conditions

Physical Performance

Outcome Measures

Primary Outcomes (1)

  • Athletic Performance

    Changes in one repetition maximum muscular strength of upper and lower body

    baseline and post 16 week intervention

Secondary Outcomes (1)

  • Total and Regional Body Composition

    baseline and post 16 week intervention

Other Outcomes (5)

  • Cardiometabolic Hormones

    baseline and post 16 week intervention

  • Aerobic Fitness

    baseline and post 12 week intervention

  • Hunger Ratings

    baseline and post 12 week intervention

  • +2 more other outcomes

Study Arms (2)

Whey Protein and exercise training

EXPERIMENTAL

Six meals per day of 20 grams of protein, two of which were whey protein and 4 days per week of exercise training..

Behavioral: Whey Protein and exercise training

Food Protein and exercise training

EXPERIMENTAL

Six meals per day of 20 grams of protein, all of which were whole food protein and 4 days per week of exercise training.

Behavioral: Food Protein and exercise training

Interventions

Whey Protein and exercise trainingBEHAVIORAL

Six meals per day four of which were whole food and two of whey protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training

Whey Protein and exercise training
Food Protein and exercise trainingBEHAVIORAL

Six meals per day all of which were whole food protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training

Food Protein and exercise training

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Each participant was screened prior to participating in the study using the Health and Fitness History, Physical Activity, and Physical Activity Readiness questionnaires administered by the investigators.
  • Medical clearance was secured from the participant's primary care physician to verify no cardiovascular,metabolic or orthopedic issues that would prohibit them from performing the exercises for the duration of the study period
  • Depending on the outcome of the health history, fitness and activity questionnaires and the physician's clearance, participants were informed of eligibility to participate in the study. A group meeting was scheduled for all eligible and interested participants to review the entire study. This process took place prior to administering any tests.

You may not qualify if:

  • Participants were excluded if they smoked, had a whey protein intolerance, or orthopedic conditions that prohibited them from engaging in strenuous exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Whey ProteinsExercise

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paul j Arciero, Phd

    Skidmore College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 3, 2015

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

August 1, 2013

Last Updated

November 3, 2015

Record last verified: 2015-10