NCT01900548

Brief Summary

The aim of this study is to investigate potential metabolic effects of whey protein high in protein and high in leucine(HPHL) compared to soy protein high in protein and low in leucine(HPLL) in osteopenic patients in a randomized controlled intervention study. The investigator hypothesize that HPHL will increase physical function and the ratio muscle mass / fat mass in this condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration 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

June 10, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 7, 2017

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

June 10, 2013

Last Update Submit

April 5, 2017

Conditions

Osteopenia

Keywords

OsteopeniaSarcopeniaOsteoporosisPhysical functionBody compositionMuscle proteinLeucineKetogenic amino acidsResistance TrainingWhey proteinSoy proteinBone turnover

Outcome Measures

Primary Outcomes (3)

  • 4 meter gait speed

    We will measure changes in 4 meter gait speed.

    Baseline and 4 months

  • Walk distance

    We will measure changes in walk distance with the Six-Minute Walk Test.

    Baseline and 4 months

  • Lean body mass(LBM)/Fat mass (FM) ratio.

    We will measure changes in the ratio LBM/FM with a DEXA-scanner.

    Baseline and 4 months

Study Arms (3)

Whey protein (HPHL)

EXPERIMENTAL

Whey protein supplementation and resistance training for four month.

Dietary Supplement: Whey protein (HPHL)Other: Resistance training

Soy protein (HPLL)

EXPERIMENTAL

Soy protein supplementation and resistance training for four month.

Dietary Supplement: Soy protein (HPLL)Other: Resistance training

Placebo (P)

PLACEBO COMPARATOR

Maltodextrin supplementation and resistance training for four month.

Dietary Supplement: Placebo (P)Other: Resistance training

Interventions

Whey protein (HPHL)DIETARY_SUPPLEMENT

The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day.

Whey protein (HPHL)
Soy protein (HPLL)DIETARY_SUPPLEMENT

The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day.

Soy protein (HPLL)
Placebo (P)DIETARY_SUPPLEMENT

Will not be given protein but the same energy content using maltodextrin (in a blended fashion).

Placebo (P)
Resistance trainingOTHER

For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.

Placebo (P)Soy protein (HPLL)Whey protein (HPHL)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteopenia defined as BMD T-score \<-1

You may not qualify if:

  • Vitamin D deficiency defined as 25-hydroxyvitamin D (25-OH-D) below 30 nmol/l.
  • Liver and kidney disease.
  • Known diabetes or Hgb1c ≥6,5% (≥48mmol/l).
  • Severe heart disease (NYHA-Class \>2).
  • Oral corticosteroid treatment within the last 3 month.
  • Anamnestic information of hip fracture or vertebral fracture.
  • Any antiosteoporotic treatment.
  • participation in other intervention studies within the last 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of endocrinology, Aarhus University hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicSarcopeniaOsteoporosis

Interventions

Whey ProteinsSoybean ProteinsResistance Training

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant ProteinsPlant Proteins, DietarySoy FoodsVegetable ProductsVegetablesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bjørn Richelsen, Professor

    The department of endocrinology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 10, 2013

First Posted

July 16, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

April 7, 2017

Record last verified: 2013-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)