NCT02593656

Brief Summary

This study systematically quantified the effects of a protein pacing energy and performance (IEPS) meal pattern compared to a standard recommended control (C) diet both of which were combined with a 4-day/week exercise training program on total and regional (abdominal) body composition (lean mass and fat mass), muscular strength and performance, flexibility, blood lipids and glucose, hormones, mood state and energy metabolism in 60 healthy middle-aged (25-55 years old) men and women following a 12-week intervention. Participants were enrolled in one of two cohorts:

  1. 1.Experimental, 2g/kg/Body Weight (BW) Protein (IEPS) (n=30)
  2. 2.Control, 1g/kg/Body Weight Protein (C) (n=30)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

October 29, 2015

Last Update Submit

April 24, 2022

Conditions

Keywords

protein ingestionresistance exerciseinterval exercisestretching exerciseendurance exercise

Outcome Measures

Primary Outcomes (1)

  • Muscular Strength and Power

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

    baseline and post 12 week intervention

Secondary Outcomes (1)

  • Total and Regional Body Composition

    baseline and post 12 week intervention

Other Outcomes (3)

  • Arterial function

    baseline and post 12 week intervention

  • Blood Lipids

    baseline and post 12 week intervention

  • Energy Metabolism

    baseline and post 12 week intervention

Study Arms (2)

High Protein

EXPERIMENTAL

Ingestion of 2.0 grams of protein per kilogram of body weight per day combined with exercise training

Behavioral: High Protein

Normal Protein

ACTIVE COMPARATOR

Ingestion of 1.0 gram of protein per kilogram of body weight per day combined with exercise training

Behavioral: Normal Protein

Interventions

High ProteinBEHAVIORAL

Protein-pacing throughout the day and exercise training for 12 weeks

High Protein
Normal ProteinBEHAVIORAL

Normal protein intake throughout the day and exercise training for 12 weeks

Normal Protein

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants will be non-smoking, healthy, men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and approval by their physicians to participate. All participants will be active (\>30 min, 4d/wk of structured physical activity \> 3 years) as assessed by a Physical Activity questionnaire, normal weight (BMI=20-27.5 kg/m2; % body fat\<30%), middle aged (25-55 years), and weight stable (+/-2kg) for at least 6 months prior to beginning the study

You may not qualify if:

  • Individuals will be excluded from participation for the following reasons: orthopedic conditions that preclude or limit participation in the exercise training (RISE); history of cardiometabolic disease (e.g., diabetes, heart disease, etc.) and/or cancer; pregnant or may be pregnant; or allergic to milk products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Paul J Arciero, Phd

    Skidmore College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 2, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

May 2, 2022

Record last verified: 2022-04