Effects of High-energy Nutritional Protein-based Bar on t... | NCT07065513

Studies
Effects of High-energy Nutritional Protein-based Bar on the Performance of Young Athletes

NCT07065513

Sponsor

Superior University

Status

Active, not recruiting

Last Update Posted

Jul 15, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Enduring Personality Change

Interventions

Normal diet
Normal diet plus nutritional protein-based bar

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Feb 28, 2026Estimated

First Submitted Date

Jun 28, 2025

First Submission Date that Met QC Criteria

Jul 13, 2025

First Posted Date

Jul 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2025

Last Update Posted Date

Jul 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A study will be conducted in Lahore. Non probability convenience sampling technique will be applied on patients who will be allocated through computerized randomization into group A & group B to collect data.

Detailed Description

Group A will be given normal diet and group B will be given normal diet in addition to protein bars. The study will be completed within the time duration of nine months. Primary Outcome measures of the research will be protein effects and quality of life in protein deficiency malnourished children. Data will be analyzed using SPSS software version 25.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal diet	Experimental		Diagnostic Test: Normal diet
Normal diet plus nutritional protein-based bar	Experimental		Combination Product: Normal diet plus nutritional protein-based bar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Normal diet	Diagnostic Test	Normal diet (control group, 20 participants: 10 boys and 10 girls).	Normal diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-Administered Questionnaire	Self-Administered Questionnaire for getting different values and measurements according to the healthcare values to check the nutritional effects on the body	12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Boys and girls aged 18-25 years.
Regularly playing team sports (football, volleyball, cricket).
Average of 5 hours per day spent in field activities (practice + matches).

Exclusion Criteria:

Allergies to bar ingredients (e.g., nuts).
Metabolic disorders affecting nutrient absorption.
Protein-energy malnutrition (PEM).
Hospitalized adults.
Eating disorders or diagnosed mental illness"

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lahore sports complex		Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided