NCT05228236

Brief Summary

This study aimed to investigate the effects of a newly developed plant-based protein blend regarding health and safety, body composition, and performance on healthy and physically active adult individuals, specifically team sports athletes. A randomized, double-blind, controlled trial was used to compare the effects of the plant-based protein versus whey protein, after an 8-week supplementation protocol, on body composition, biochemical markers, muscle strength and power, as well as aerobic performance in male futsal players. The working hypothesis is that this special blend of plant-based protein will be equivalent to whey protein, not only regarding body composition and performance, but also insofar as health and safety at the biochemical and physiological level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 13, 2022

Last Update Submit

January 27, 2022

Conditions

Keywords

Plant-based ProteinBody compositionPhysical PerformanceBiochemical Health MarkersSupplementation

Outcome Measures

Primary Outcomes (17)

  • Body composition parameter - change in fat free mass (FFM)

    FFM (kg) was assessed by dual energy X-ray absorptiometry

    Baseline, week 4 and week 8

  • Body composition parameter - change in fat mass (FM)

    FM (%) was assessed by dual energy X-ray absorptiometry

    Baseline, week 4 and week 8

  • Body composition parameter - change in muscle thickness

    muscle thickness of the rectus femoris (mm) was assessed by ultrasonography

    Baseline, week 4 and week 8

  • Body composition parameter - change in body water

    total body water, intracellular water and extracellular water (L) were assessed by bioelectrical impedance analysis

    Baseline, week 4 and week 8

  • Performance parameter - change in strength

    Maximal isometric forearm strength (N) was assessed using a handgrip dynamometer

    Baseline, week 4 and week 8

  • Performance parameter - change in maximum strength

    Maximum strength (kg) was predicted from 1-RM in back squat and bench press exercises using a Multipower machine withVitruve technology

    Baseline, week 4 and week 8

  • Performance parameter - change in peak power

    Muscle power (Watt) was assessed with a supramaximal cycling test on cycle ergometer

    Baseline, week 4 and week 8

  • Performance parameter - change in jump height

    Vertical jump height (cm) was assessed on a multicomponent force platform interfaced with the Chronojump software

    Baseline, week 4 and week 8

  • Aerobic performance - change in Oxygen uptake

    VO2peak (mL.kg-1.min-1) was assessed using breath-by-breath gas analyzer in an incremental test performed on a treadmill

    Baseline, week 4 and week 8

  • Aerobic performance - change in Oxygen uptake

    Maximal aerobic speed (km/h) was assessed in an incremental test performed on a treadmill

    Baseline, week 4 and week 8

  • biochemical health markers - change in cortisol

    Salivary cortisol was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

  • biochemical health markers - change in creatinine

    plasma creatinine was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

  • biochemical health markers - change creatine kinase

    plasma creatine kinase was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

  • biochemical health markers - change in glucose

    plasma glucose was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

  • biochemical health markers - change in C reactive protein

    plasma C Reactive Protein was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

  • biochemical health markers - change in Aspartate Aminotransferase

    plasma Aspartate Aminotransferase was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

  • biochemical health markers - change in alanine aminotransferase

    Plasma alanine aminotransferase was assessed using spectrophotometry techniques in an automated equipment.

    Baseline, week 4 and week 8

Secondary Outcomes (2)

  • Body composition parameter - change in phase angle

    Baseline, week 4 and week 8

  • Body composition parameter - change of visceral fat

    Baseline, week 4 and week 8

Study Arms (2)

Plant based protein

EXPERIMENTAL
Dietary Supplement: Plant based protein

Whey Protein

EXPERIMENTAL
Dietary Supplement: Whey protein

Interventions

Plant based proteinDIETARY_SUPPLEMENT

A single dose of \~30 g of a plant-based protein blend was ingested 30-60 min after physical practice in training days or 30-60 min before bedtime in resting days.

Plant based protein
Whey proteinDIETARY_SUPPLEMENT

A single dose of \~30 g of whey protein was ingested 30-60 min after physical practice in training days or 30-60 min before bedtime in resting days.

Whey Protein

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects currently engaged in a Futsal training program in a competition team, currently engaged in practice for at least 1 year and at least 3 times per week.

You may not qualify if:

  • Individuals taking any type of drug (including anabolic steroids), medicines or supplements that may enhance body composition or performance, 3 months prior to the beginning of the trial.
  • Clinical diagnose of a disease that might compromise tolerance to the supplements or influence body composition or performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bettery S.A.

Oeiras, Porto Salvo, 2740-262, Portugal

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Innovation Manager

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 8, 2022

Study Start

September 1, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations