NCT05307159

Brief Summary

Background: Sport is a specialized competitive physical activity that is regulated and requires daily physical training. The workouts allow athletes to increase strength, endurance exercise performance, and muscle mass. Due to this, it is extremely important to consider that high-performance athletes require a meal plan with a higher energy requirement compared to a normal person who does not perform high-intensity activity. The diet of these athletes needs higher protein requirements to support the accumulation and/or maintenance of lean mass. Specifically athletes between 4 to 17 years of age, the protein requirement is of utmost importance to maintain muscle mass between 68-73%. Therefore, the recommendations for protein intake for athletes in this age range is approximately between 10 and 30% of the total energy intake. One of the strategies that has been used is supplementation with protein isolates, since in this way there is greater protein accessibility to maintain a balance between protein synthesis and degradation. The main protein supplements that are currently consumed come from proteins of animal origin; however, these usually have high costs, which makes them difficult to access for the population. Due to this, strategies have begun to be sought through the use of different proteins to generate similar effects. Objective: To evaluate the effect of a bean protein supplement on body composition in high-performance adolescent athletes. Methodology: The protocol will be divided into two stages, in the first one a supplement added with bean protein will be elaborated. First, the extraction of protein from the bean will be carried out, then it will be subjected to a heat treatment to eliminate anti-nutrients and finally its chemical composition will be analyzed. In the second stage, a pilot study will be carried out to evaluate the effect of the bean protein supplement in high-performance adolescent athletes. High-performance table tennis athletes, adolescents who agree to collaborate with the study will be included. Bean protein supplementation will be for 21 continuous days in the athletes' snack. Anthropometric measurements will be taken at the beginning and at the end of the intervention. A control of the diet and supplementation of the athletes will be carried out with the support of their coaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

March 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

March 23, 2022

Last Update Submit

September 1, 2022

Conditions

Keywords

teenagersbeansupplementmuscle masssporty

Outcome Measures

Primary Outcomes (1)

  • Kilograms of muscle mass

    Muscle tissue in relation to total body weight and is estimated from body folds

    21 days

Secondary Outcomes (2)

  • Percentage of fat Mass

    21 days

  • Kilograms of body weight

    21 days

Study Arms (1)

bean protein supplement

EXPERIMENTAL

The supplement will be consumed daily for 21 days in the athletes' snack, the supplement contains 7 g of bean protein mixed in 60 mL of milk and 60 mL of strawberry drinkable yogurt

Dietary Supplement: bean protein supplement

Interventions

bean protein supplementDIETARY_SUPPLEMENT

They will have a snack with bean protein for 21 days Participants will follow their usual diet, which will be quantified and evaluated.

bean protein supplement

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Athletes who play table tennis
  • Age between 11 and 18 years
  • Male and female
  • Signature of informed consent by parents or guardians
  • Approval of the informed assent by the minor under 18 years of age

You may not qualify if:

  • High-performance athletes who are injured
  • Athletes who are not carrying out a quantified diet
  • Athletes who present any pathology and/or consume any medication
  • Athlete who consumes another nutritional supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional de Alta Especialidad de la Península de Yucatán

Mérida, Yucatán, 97130, Mexico

Location

Related Publications (4)

  • Nemet D, Eliakim A. Pediatric sports nutrition: an update. Curr Opin Clin Nutr Metab Care. 2009 May;12(3):304-9. doi: 10.1097/MCO.0b013e32832a215b.

    PMID: 19337125BACKGROUND
  • Shenoy S, Dhawan M, Singh Sandhu J. Four Weeks of Supplementation With Isolated Soy Protein Attenuates Exercise-Induced Muscle Damage and Enhances Muscle Recovery in Well Trained Athletes: A Randomized Trial. Asian J Sports Med. 2016 May 23;7(3):e33528. doi: 10.5812/asjsm.33528. eCollection 2016 Sep.

    PMID: 27826398BACKGROUND
  • Tang JE, Moore DR, Kujbida GW, Tarnopolsky MA, Phillips SM. Ingestion of whey hydrolysate, casein, or soy protein isolate: effects on mixed muscle protein synthesis at rest and following resistance exercise in young men. J Appl Physiol (1985). 2009 Sep;107(3):987-92. doi: 10.1152/japplphysiol.00076.2009. Epub 2009 Jul 9.

    PMID: 19589961BACKGROUND
  • Avila-Nava A, Noriega LG, Tovar AR, Granados O, Perez-Cruz C, Pedraza-Chaverri J, Torres N. Food combination based on a pre-hispanic Mexican diet decreases metabolic and cognitive abnormalities and gut microbiota dysbiosis caused by a sucrose-enriched high-fat diet in rats. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201501023. Epub 2016 Aug 8.

    PMID: 27352915BACKGROUND

MeSH Terms

Conditions

Spinocerebellar Ataxia 31

Study Officials

  • Azalia Ávila-Nava

    Hospital Regional de Alta Especialidad de la Península de Yucatán

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 1, 2022

Study Start

May 2, 2022

Primary Completion

July 4, 2022

Study Completion

August 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations