NCT02675348

Brief Summary

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

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 Jan 2016

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

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

February 2, 2016

Last Update Submit

May 7, 2017

Conditions

Outcome Measures

Primary Outcomes (9)

  • Body composition

    Fat-Free mass

    10 weeks

  • Body composition

    Fat mass

    10 Weeks

  • Muscular thickness

    vastus medialis thickness

    10 weeks

  • Endurance Performance

    Vo2max

    10 weeks

  • Endurance Performance

    Ventilatory threshold 2

    10 Weeks

  • Blood Markers

    haemoglobin

    10 weeks

  • Blood Markers

    red blood cell

    10 weeks

  • Blood Markers

    haematocrit

    10 weeks

  • Blood Markers

    transferrin

    10 weeks

Secondary Outcomes (3)

  • Immunology markers

    10 weeks

  • Immunology markers

    10 weeks

  • Immunology markers

    10 weeks

Study Arms (3)

Dietary Supplement: Beef Protein

EXPERIMENTAL

All the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of beef protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days).

Dietary Supplement: Dietary Supplement: Beef Protein

Dietary Supplement: Whey Protein

EXPERIMENTAL

All the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of whey protein powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days).

Dietary Supplement: Dietary Supplement: whey Protein

Dietary Supplement: CHO

ACTIVE COMPARATOR

All the groups will perform a similar endurance training involved 4 to 6 workout per week with a total percentage distribution of 75 to 80% at low intensity; 10% at moderate intensity, and 15 to 10% at high intensity. Training session will last from 45 min to a maximum of 120 min. Intervention will last for 10 weeks. Participants will ingest 20g of maltodextrin powder mixed with 250ml of water at post workout (training days) or before breakfast (non training days).

Dietary Supplement: Dietary Supplement: CHO

Interventions

Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of beef protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

Also known as: 100% all beef
Dietary Supplement: Beef Protein

Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of whey protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

Also known as: Whey protein powder
Dietary Supplement: Whey Protein
Dietary Supplement: CHODIETARY_SUPPLEMENT

Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of maltdextrin after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes

Also known as: maltodextrin
Dietary Supplement: CHO

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • regularly trained endurance athletes,
  • aged 30 to 60 years old,
  • minimum 2 years of experience,
  • 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

Study Sites (1)

Department of Life and Sports Science

Chatham, Kent, ME4 4TB, United Kingdom

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

  • Fernando Naclerio, Ph D

    University of Greenwich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Lecturer

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 5, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

May 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations