NCT03033953

Brief Summary

The aim of this study is to investigate the long term adaptations to 11 (elderly) or 12 (young) weeks of strength training when supplemented with native whey or milk. The investigators hypothesize that native whey will give greater increases in muscle hypertrophy and strength than milk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable healthy

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

August 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

January 19, 2017

Last Update Submit

January 24, 2017

Conditions

HealthyYoungElderly

Outcome Measures

Primary Outcomes (2)

  • Lean mass

    Measured by whole body dual x-ray absorptiometry (DXA)

    Before the training intervention

  • Lean mass

    Measured by whole body dual x-ray absorptiometry (DXA)

    After 11-12 weeks of strength training

Secondary Outcomes (226)

  • Thigh muscle cross sectional area

    Before the training intervention

  • Thigh muscle cross sectional area

    After 11-12 weeks of strength training

  • Pectoralis muscle cross sectional area

    Before the training intervention

  • Pectoralis muscle cross sectional area

    After 11-12 weeks of strength training

  • Arm cross sectional area

    Before the training intervention

  • +221 more secondary outcomes

Study Arms (2)

Milk supplementation

PLACEBO COMPARATOR

11 (elderly) or 12 (young) weeks of strength training and daily supplementation of 2x20g milk protein.

Dietary Supplement: MilkOther: Strength training

Native whey

EXPERIMENTAL

11 (elderly) or 12 (young) weeks of strength training and daily supplementation of 2x20g native whey protein.

Dietary Supplement: Native wheyOther: Strength training

Interventions

Native wheyDIETARY_SUPPLEMENT
Native whey
MilkDIETARY_SUPPLEMENT
Milk supplementation
Strength trainingOTHER
Milk supplementationNative whey

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy in the sense that they can conduct training and testing
  • Able to understand Norwegian language written and oral
  • Between 20 and 45, or above 70 years of age

You may not qualify if:

  • Diseases or injuries contraindicating participation
  • Use of dietary supplements (e.g. proteins, vitamins and creatine)
  • Lactose intolerance
  • Allergy to milk
  • Allergy towards local anesthetics (xylocain)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, Oslo County, 0863, Norway

Location

MeSH Terms

Interventions

MilkResistance Training

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 27, 2017

Study Start

August 1, 2014

Primary Completion

June 1, 2015

Study Completion

November 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations

NO(1)