NCT07065513

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 28, 2025

Last Update Submit

July 13, 2025

Conditions

Enduring Personality Change

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Normal dietDIAGNOSTIC_TEST

Normal diet (control group, 20 participants: 10 boys and 10 girls).

Normal diet
Normal diet plus nutritional protein-based barCOMBINATION_PRODUCT

: Normal diet plus nutritional protein-based bar (intervention group, 20 participants: 10 boys and 10 girls). The participants will consume 3 servings of 14g each per day, providing 6.8g protein and 283 kcal

Normal diet plus nutritional protein-based bar

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore sports complex

Lahore, Punjab Province, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 15, 2025

Study Start

March 1, 2025

Primary Completion

August 1, 2025

Study Completion

February 28, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)