NCT02954367

Brief Summary

The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular endurance training programme on (a) body composition (b) performance (c) muscle structure (d) immunology and (e) microbiota (f) haematological markers in endurance athletes

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Status
unknown

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

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 19, 2016

Last Update Submit

November 1, 2016

Conditions

Dietary Modification

Outcome Measures

Primary Outcomes (4)

  • % Fat Mass (Body composition)

    Estimated with Densitometry (DEXA)

    10 weeks

  • Visceral Adipose Tissue Mass (g) (Body composition)

    Estimated with DEXA

    10 weeks

  • Total Fat Free mass (g) (Body composition)

    Estimated with DEXA

    10 weeks

  • Bone mineral density (g/cm3) (Body composition)

    Estimated with DEXA

    10 weeks

Secondary Outcomes (22)

  • Blood Glucose (mg/dl)

    10 weeks

  • Creatine Kinase (Ul/l) -Blood markers-

    10 weeks

  • Creatinine (mg/dl) - Blood markers -

    10 weeks

  • Myoglobin (ng/ml) - Blood markers -

    10 weeks

  • Total cholesterol (mg/dl) -Blood markers-

    10 weeks

  • +17 more secondary outcomes

Study Arms (2)

PROTEIN (MEAT + WHEY)

EXPERIMENTAL

Post workout (training days) or breakfast (non training days) 20g of meat protein (10g meat + 10g whey) mixed with 200ml of orange juice and water

Dietary Supplement: PROTEIN

CARBOHYDRATE (CHO)

PLACEBO COMPARATOR

Post workout (training days) or breakfast (non training days) 20g of maltodextrin mixed with 200ml orange juice and water

Dietary Supplement: CARBOHYDRATE

Interventions

PROTEINDIETARY_SUPPLEMENT

Immediately (\<10 min) after completing each training session (resistance training) participants will consume a beverage containing 20g of meat protein (10g) plus whey (10g) mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.

Also known as: 100% BEEF
PROTEIN (MEAT + WHEY)
CARBOHYDRATEDIETARY_SUPPLEMENT

Immediately (\<10 min) after completing each training session (resistance training), participants will consume a beverage containing about 20g of maltodextrin mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.

Also known as: Maltodextrin
CARBOHYDRATE (CHO)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years to 45
  • Vo2max \>50ml/kg/min
  • Regularly trained athletes,
  • Minimum 3 years of experience in resistance training exercise,
  • Volunteers,

You may not qualify if:

  • any musculoskeletal injuries, metabolic conditions, or diseases;
  • use of medications, smoking, and nutritional supplements known to affect physical performance, muscle damage or recovery process (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Moreno-Perez D, Lopez-Samanes A, Larrosa M, Larumbe-Zabala E, Centeno A, Roberts J, Naclerio F. Effects of protein-carbohydrate vs. carbohydrate alone supplementation on immune inflammation markers in endurance athletes: a randomized controlled trial. Eur J Appl Physiol. 2023 Jul;123(7):1495-1505. doi: 10.1007/s00421-023-05168-6. Epub 2023 Mar 14.

    PMID: 36918416DERIVED

MeSH Terms

Interventions

ProteinsRed MeatCarbohydratesmaltodextrin

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsMeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • DIEGO MORENO, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

  • FERNANDO NACLERIO, PhD

    University of Greenwich

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 19, 2016

First Posted

November 3, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Last Updated

November 3, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share