NCT03561337

Brief Summary

Twenty-four well trained runners (VO2max 60.73.7 ml O2 Kg-1 min1) completed a six week block randomized controlled intervention period. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO2max, training and performance status. The PRO- CHO group ingested a protein beverage (0.3g kg-1) before and protein-carbohydrate beverage (0.3g protein kg-1 and 0.1g carbohydrate kg-1) after each exercise session. The CHO group ingested energy matched carbohydrate. Post-absorptive muscle biopsies were obtained pre and post intervention for analysis HAD, CS and PGC-1. Subjects completed two physical tests 6 km performance test (pre, week 1 and week 6) and aVo2max test (pre and post intervention).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

December 1, 2017

Last Update Submit

May 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    maximal oxygen uptake (L O2/min)

    Change from week 1 to week 6

Secondary Outcomes (6)

  • VDAC

    Change from week 1 to week 6

  • CytC

    Change from week 1 to week 6

  • Performance

    Change from week 1 to week 6

  • COX-IV

    Change from week 1 to week 6

  • HSP60

    Change from week 1 to week 6

  • +1 more secondary outcomes

Study Arms (2)

PROTEIN-CARBOHYDRATE

EXPERIMENTAL

Intervention group receiving protein and carbohydrate supplement

Dietary Supplement: PROTEIN-CARBOHYDRATE

CARBOHYDRATE

PLACEBO COMPARATOR

Intervention groups receiving carbohydrate supplement

Dietary Supplement: CARBOHDYRATE

Interventions

PROTEIN-CARBOHYDRATEDIETARY_SUPPLEMENT

PRO before and PRO-CHO after training

PROTEIN-CARBOHYDRATE
CARBOHDYRATEDIETARY_SUPPLEMENT

CHO before and after training

CARBOHYDRATE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • maximal oxygen uptake (VO2max) of \>50ml O2 kg-1 min-1 for women and \>55ml O2 kg-1 min-1 for men,
  • running at least 3 times a week and
  • running being the primarily training form

You may not qualify if:

  • use of medicine
  • diagnosed metabolic diseases
  • injuries which hindered running and body mass index (BMI) \< 25 kg m-2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Location

Sport Science, Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Hansen M, Oxfeldt M, Larsen AE, Thomsen LS, Rokkedal-Lausch T, Christensen B, Rittig N, De Paoli FV, Bangsbo J, Ortenblad N, Madsen K. Supplement with whey protein hydrolysate in contrast to carbohydrate supports mitochondrial adaptations in trained runners. J Int Soc Sports Nutr. 2020 Sep 7;17(1):46. doi: 10.1186/s12970-020-00376-3.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: block randomized controlled intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 1, 2017

First Posted

June 19, 2018

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

June 1, 2014

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations