Enduring Personality ChangeNCT07065513
Effects of High-energy Nutritional Protein-based Bar on the Performance of Young Athletes
A study testing Normal diet and Normal diet plus nutritional protein-based bar in people with Enduring Personality Change, run by Superior University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Enduring Personality Change
- What is being tested?
- Normal diet and Normal diet plus nutritional protein-based bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Allergies to bar ingredients (e.g., nuts).
- Metabolic disorders affecting nutrient absorption.
- Protein-energy malnutrition (PEM).
- Hospitalized adults.
- Eating disorders or diagnosed mental illness"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Energy Nutritional Protein Based Bar on Performance of Young Athletes
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.
Read the 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.
- Conditions
- Enduring Personality Change
- Being tested
- Normal diet, Normal diet plus nutritional protein-based bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dietDiagnostic test
Normal diet (control group, 20 participants: 10 boys and 10 girls).
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
| Study group | Role | What they receive |
|---|---|---|
| Normal diet | Experimental | Not described Receives: Diagnostic Test: Normal diet |
| Normal diet plus nutritional protein-based bar | Experimental | Not described Receives: Combination Product: Normal diet plus nutritional protein-based bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enduring Personality ChangeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065513
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/927
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Energy Nutritional Protein Based Bar on Performance of Young Athletes
- ClinicalTrials.gov ID
- NCT07065513
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/927
- Conditions
- Enduring Personality Change
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diet | Experimental | Diagnostic Test: Normal diet |
| Normal diet plus nutritional protein-based bar | Experimental | Combination Product: Normal diet plus nutritional protein-based bar |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- Allergies to bar ingredients (e.g., nuts).
- Metabolic disorders affecting nutrient absorption.
- Protein-energy malnutrition (PEM).
- Hospitalized adults.
- Eating disorders or diagnosed mental illness"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal dietNormal diet (control group, 20 participants: 10 boys and 10 girls). | Diagnostic test | Normal diet |
| Normal diet plus nutritional protein-based bar: 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 | Combination product | Normal diet plus nutritional protein-based bar |
Primary outcome
Self-Administered Questionnaire
Time frame: 12 Months
Self-Administered Questionnaire for getting different values and measurements according to the healthcare values to check the nutritional effects on the body
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet and Normal diet plus nutritional protein-based bar in people with Enduring Personality Change, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Administered Questionnaire (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.