DyslipidemiaNCT07627555
Polyunsaturated Fatty Acids-based Bars Effect on Metabolic Syndrome Patients
A study testing Jelly Candy and PUFA Bar in people with Dyslipidemia and Metabolic Syndrome (MetS), run by University of Lahore at 1 site in Pakistan.
Trial summary
This study aimed to manage dyslipidemia through Polyunsaturated fatty acids based bar among patients with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Dyslipidemia, Metabolic Syndrome (MetS)
- What is being tested?
- Jelly Candy and PUFA Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Feb 2025to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic syndrome patient's age 40 to 65 years with BMI (above 25 kg/m 2 ) was major part of this study.
- Patients having Triglyceride levels range from mild to moderate (150 to 499 mg/dL) are included in the study.
- Patients having LDL (Low density lipoprotein) range from mild (130-159 mg/dL) to moderate (160-189 mg/dL) are included in the study.
- Patients having HDL (High-density lipoprotein) range from mild to moderate (60 mg/dL or higher) have been included in the study.
Who cannot join
- Lactating and pregnant women will not be included.
- Patients who are using any kind of medicine.
- Any person allergic to nuts.
- Adults suffering from critical health conditions, including cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Polyunsaturated Fatty Acids-based Bars on Lipid Profile Among Patients With Metabolic Syndrome
This study aimed to manage dyslipidemia through Polyunsaturated fatty acids based bar among patients with metabolic syndrome.
Read the detailed description
This study was conducted at Chaudhry Muhammad Akram Teaching \& Research Hospital, Lahore. Total 60 individuals diagnosed with metabolic syndrome, like deranged lipid profile, high blood pressure (ranges mild to moderate), and elevated levels of HbA1c (5.6%-6.4%), aged between 40 to 65 years were part of the study. The participants were randomly selected and divided into two groups.
Control group (T 0 ) was given one jelly candy as mid-morning snack. The experimental group (T 1 ) was given PUFA bar one each daily The follow-up for patients has been conducted monthly, all laboratory test (blood pressure, lipid profile, HbA1c and CRP) has been done on 1st and after 8 weeks. The baseline and post-test study data is compared to test the study hypothesis.
- Conditions
- Dyslipidemia, Metabolic Syndrome (MetS)
- Being tested
- Jelly Candy, PUFA Bar
- Keywords
- lipid profile, omega 3 fatty acids, metabolic syndrome, cardiovascular diseases, poly unsaturated fatty acids
- Medical subject headings
- Dyslipidemias, Metabolic Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jelly CandyDietary supplement
participants were advised to take one jelly candy as a mid-morning snack for a duration of 2 months.
PUFA BarDietary supplement
Participants were advised to taken one PUFA bar as a mid- morning snack for a duration of 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group T0 | Placebo comparator | participants have taken one jelly candy as a mid-morning snack for a duration of 2 months. Receives: Dietary Supplement: Jelly Candy |
| Experimental group T1 | Experimental | participants have taken one PUFA bar as a mid- morning snack for a duration of 2 months. Receives: Dietary Supplement: PUFA Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
BMI is defined as body weight in kilograms divided by height in meters squared (kg/m²). BMI cut-off points are used to assess weight status, categorizing individuals as underweight, normal, overweight or obese. Obesity is further classified into grades 1, 2 and 3.
Measured: 60 days
Lipid Profile
Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides levels were measured.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start6 Feb 2025
- Primary completion15 May 2025
- Study completion16 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aslam, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627555
- Sponsor's protocol ID
- IRB-UOL-FAHS/570/2025
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Polyunsaturated Fatty Acids-based Bars on Lipid Profile Among Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07627555
- Acronym / sponsor ID
- IRB-UOL-FAHS/570/2025
- Conditions
- Dyslipidemia, Metabolic Syndrome (MetS)
- Keywords
- lipid profile, omega 3 fatty acids, metabolic syndrome, cardiovascular diseases, poly unsaturated fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 16 Jul 2025 (actual)
- First posted
- 4 Jun 2026 (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.
This study aimed to manage dyslipidemia through Polyunsaturated fatty acids based bar among patients with metabolic syndrome.
Detailed description
This study was conducted at Chaudhry Muhammad Akram Teaching \& Research Hospital, Lahore. Total 60 individuals diagnosed with metabolic syndrome, like deranged lipid profile, high blood pressure (ranges mild to moderate), and elevated levels of HbA1c (5.6%-6.4%), aged between 40 to 65 years were part of the study. The participants were randomly selected and divided into two groups.
Control group (T 0 ) was given one jelly candy as mid-morning snack. The experimental group (T 1 ) was given PUFA bar one each daily The follow-up for patients has been conducted monthly, all laboratory test (blood pressure, lipid profile, HbA1c and CRP) has been done on 1st and after 8 weeks. The baseline and post-test study data is compared to test the study hypothesis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group T0 | Placebo comparator | Dietary Supplement: Jelly Candyparticipants have taken one jelly candy as a mid-morning snack for a duration of 2 months. |
| Experimental group T1 | Experimental | Dietary Supplement: PUFA Barparticipants have taken one PUFA bar as a mid- morning snack for a duration of 2 months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Metabolic syndrome patient's age 40 to 65 years with BMI (above 25 kg/m 2 ) was major part of this study.
- Patients having Triglyceride levels range from mild to moderate (150 to 499 mg/dL) are included in the study.
- Patients having LDL (Low density lipoprotein) range from mild (130-159 mg/dL) to moderate (160-189 mg/dL) are included in the study.
- Patients having HDL (High-density lipoprotein) range from mild to moderate (60 mg/dL or higher) have been included in the study.
Key exclusion criteria (4 listed)
- Lactating and pregnant women will not be included.
- Patients who are using any kind of medicine.
- Any person allergic to nuts.
- Adults suffering from critical health conditions, including cancer.
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 |
|---|---|---|
| Jelly Candyparticipants were advised to take one jelly candy as a mid-morning snack for a duration of 2 months. | Dietary supplement | Control group T0 |
| PUFA BarParticipants were advised to taken one PUFA bar as a mid- morning snack for a duration of 2 months. | Dietary supplement | Experimental group T1 |
Primary outcome
Body Mass Index
Time frame: 60 days
BMI is defined as body weight in kilograms divided by height in meters squared (kg/m²). BMI cut-off points are used to assess weight status, categorizing individuals as underweight, normal, overweight or obese. Obesity is further classified into grades 1, 2 and 3.
Lipid Profile
Time frame: 60 days
Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides levels were measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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 Jelly Candy and PUFA Bar in people with Dyslipidemia and Metabolic Syndrome (MetS), run by University of Lahore 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Body Mass Index (time frame: 60 days). The study lists 2 primary outcomes in all. 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 4 Jun 2026.