NCT03600311

Brief Summary

The purpose of this study is to determine if post-exercise protein supplementation can rescue the anabolic response of muscle and bone to resistance exercise during caloric restriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 9, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

July 9, 2018

Last Update Submit

June 10, 2019

Conditions

Weight LossStarvation

Outcome Measures

Primary Outcomes (6)

  • Change in Serum [IGF-1] (ng/mL)

    Measured via ELISA

    Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

  • Change in Serum [GH] (pg/mL)

    Measured via ELISA

    Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

  • Change in Serum [IGFBP-3] (ng/mL)

    Measured via ELISA

    Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

  • Change in Serum [P1NP] (pg/mL)

    Measured via ELISA

    Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

  • Change in Serum [CTX] (ng/mL)

    Measured via ELISA

    Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

  • Change in Serum [Sclerostin] (pmol/L)

    Measured via ELISA

    Baseline, Pre-Exercise, 0-24 Hours Post-Exercise

Secondary Outcomes (3)

  • Change in Body Weight (kg)

    Baseline and Day 4

  • Change in Body Fat Percentage (%)

    Baseline and Day 4

  • Change in Perceived Hunger (mm or %)

    Baseline and Day 4

Study Arms (3)

Energy Balance

PLACEBO COMPARATOR

Participants will be in energy balance and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

Other: Energy BalanceDietary Supplement: Post-Exercise CarbohydrateDietary Supplement: Calcium and Vitamin D

Caloric Restriction and CHO Supp

ACTIVE COMPARATOR

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of maltodextrin following exercise.

Other: Caloric RestrictionDietary Supplement: Post-Exercise CarbohydrateDietary Supplement: Calcium and Vitamin D

Caloric Restriction and PRO Supp

EXPERIMENTAL

Participants will be calorie restricted to 15 kcal/kg FFM/day and consume 1.2 g/kg BW protein. They will be provided 30 g of whey protein following exercise.

Other: Caloric RestrictionDietary Supplement: Post-Exercise ProteinDietary Supplement: Calcium and Vitamin D

Interventions

Caloric RestrictionOTHER

Participants will consume 15 kcal/kg FFM/day.

Caloric Restriction and CHO SuppCaloric Restriction and PRO Supp
Post-Exercise ProteinDIETARY_SUPPLEMENT

Participants will ingest 30 g of protein following exercise.

Caloric Restriction and PRO Supp
Energy BalanceOTHER

Participants will consume 40 kcal/kg FFM/day.

Energy Balance
Post-Exercise CarbohydrateDIETARY_SUPPLEMENT

Participants will ingest 30 g of carbohydrate following exercise.

Caloric Restriction and CHO SuppEnergy Balance
Calcium and Vitamin DDIETARY_SUPPLEMENT

Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.

Caloric Restriction and CHO SuppCaloric Restriction and PRO SuppEnergy Balance

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Weigh at least 110 lbs
  • Weight-Stable (2.5 kg) within the past six months
  • Height-Stable (\< 0.25 inches) within the past year
  • years of resistance training experience
  • \- \<20% body fat (men) or \<30% body fat (women)

You may not qualify if:

  • Lactose intolerant
  • Pregnancy
  • Taking interfering medications such as steroids, thyroid or growth hormones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports and Exercise Nutrition Laboratory, Department of Nutrition and Health Sciences, Ruth Leverton Hall

Lincoln, Nebraska, 68583, United States

Location

MeSH Terms

Conditions

Weight LossStarvation

Interventions

Caloric RestrictionCalciumVitamin D

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Karsten Koehler

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 26, 2018

Study Start

August 31, 2018

Primary Completion

May 1, 2019

Study Completion

May 31, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)