NCT02425020

Brief Summary

The aim of this project is to investigate the potential benefits of combining a new protein meat hydrolysates extract with a regular resistance training programme on (a) body composition (b) performance (c) muscle structure (d) general markers health and immunity in athletes. As a second objective the investigators will analyse potential differences obtained from the ingestion of the new hydrolysates meat protein extract compared to the ingestion of others commercially available protein sources such as whey or casein.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

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

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

28 days

First QC Date

April 13, 2015

Last Update Submit

April 22, 2015

Conditions

Dietary Modification

Keywords

Supplementperformancewheymeatprotein

Outcome Measures

Primary Outcomes (1)

  • Body composition

    Fat Free mass and Fat Mass.

    8 weeks

Secondary Outcomes (14)

  • Muscle Structure

    8 weeks

  • Muscle damage marker

    8 weeks

  • Analysis of glycaemia

    8 weeks

  • Analysis of total cholesterol

    8 weeks

  • Analysis of HDL, cholesterol

    8 weeks

  • +9 more secondary outcomes

Study Arms (3)

Meat protein

EXPERIMENTAL

Post workout (training days) or breakfast (non training days) 20g of meat protein mixed with 250ml of orange juice and water

Dietary Supplement: Meat Protein

Whey Protein

EXPERIMENTAL

Post workout (training days) or breakfast (non training days) 20g of whey protein isolate mixed with 250ml of orange juice and water

Dietary Supplement: Whey protein

Carbohydrate

ACTIVE COMPARATOR

Post workout (training days) or breakfast (non training days) maltodextrin mixed with 250ml orange juice and water

Dietary Supplement: Carbohydrate

Interventions

Meat ProteinDIETARY_SUPPLEMENT

Immediately (\<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of meat protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.

Meat protein
Whey proteinDIETARY_SUPPLEMENT

Immediately (\<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of whey protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.

Whey Protein
CarbohydrateDIETARY_SUPPLEMENT

Immediately (\<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing about 20g of maltodextrin mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.

Carbohydrate

Eligibility Criteria

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

You may qualify if:

  • regularly trained athletes,
  • aged 18 to 45 years old,
  • minimum 3 months 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

MeSH Terms

Interventions

Meat ProteinsWhey ProteinsCarbohydrates

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMeatFood and BeveragesMilk ProteinsWheyMilkDairy Products

Study Officials

  • 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
Principal Lecturer

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 23, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04