HyperlipidemiaNCT07696559
Effect of the β-sitosterol-enriched Dietary Plan on Lipid Levels.
A study testing Treatment Group (T 2 ) in people with Hyperlipidemia and Obese Individuals, run by University of Lahore at 1 site in Pakistan.
Trial summary
The purpose of the study is to assess the effect of β -Sitosterol enriched dietary intervention on lipid profile to alleviate hyperlipidemia among Grade II obese patients Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Hyperlipidemia, Obese Individuals
- What is being tested?
- Treatment Group (T 2 )
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2026to 15 Apr 2026
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 25-55 years
- Diagnosed with hyperlipidemia (LDL ≥ 130 mg/dL or Total Cholesterol ≥ 200 mg/dL)
- BMI between 35.0-39.9 kg/m²
- Willing to follow a prescribed diet plan for the entire study duration
Who cannot join
- Patients with sitosterolemia, kidney or liver diseases
- Pregnant or lactating women
- Current use of statins, fibrates, or plant sterol supplements
- Individuals with food allergies to any prescribed ingredients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of β-sitosterol -Enriched Dietary Intervention on Lipid Profile to Alleviate Hyperlipidemia Among Grade II Obese Individuals
The purpose of the study is to assess the effect of β -Sitosterol enriched dietary intervention on lipid profile to alleviate hyperlipidemia among Grade II obese patients
Read the detailed description
The study was conducted at University of Lahore Teaching Hospital, Lahore to assess the outcomes two dietary intervention. One contains regular food diet plan for hyperlipidemic patients. While, the other plan contains all the specified food product that contains B-sitosterol compound. Then, B-sitosterol food enriched diet plan contains specified amount of this phytosterol (1.5-3g).
- Conditions
- Hyperlipidemia, Obese Individuals
- Being tested
- Control group (T 1 ), Treatment Group (T 2 )
- Keywords
- lipid profile, obese grade II, Hyperlipedemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (T 1 )Dietary supplement
The control group (T0) received hyperlipidemia controlled diet plan
Treatment Group (T 2 )Dietary supplement
the experimental group (T1) received b-sitosterol specified food products containing 2-3g/day.
| Study group | Role | What they receive |
|---|---|---|
| Control group (T 1 ) | Placebo comparator | simple lipid control diet plan Receives: Dietary Supplement: Control group (T 1 ) |
| Treatment Group (T 2 ) | Active comparator | b-sitosterol food items diet plan Receives: Dietary Supplement: Treatment Group (T 2 ) |
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: 8 weeks
Lipid Profile
Blood lipid profile will be obtained using fasting blood samples to determine serum total cholesterol, high-density lipoprotein cholesterol (HD L-C), low density lipoprotein cholesterol (LDL-C) and triglycerides.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jan 2026
- Primary completion15 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- NCT07696559
- Sponsor's protocol ID
- IRB-UOL-FAHS/251/2026
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of β-sitosterol -Enriched Dietary Intervention on Lipid Profile to Alleviate Hyperlipidemia Among Grade II Obese Individuals
- ClinicalTrials.gov ID
- NCT07696559
- Acronym / sponsor ID
- IRB-UOL-FAHS/251/2026
- Conditions
- Hyperlipidemia, Obese Individuals
- Keywords
- lipid profile, obese grade II, Hyperlipedemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 10 Jul 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.
The purpose of the study is to assess the effect of β -Sitosterol enriched dietary intervention on lipid profile to alleviate hyperlipidemia among Grade II obese patients
Detailed description
The study was conducted at University of Lahore Teaching Hospital, Lahore to assess the outcomes two dietary intervention. One contains regular food diet plan for hyperlipidemic patients. While, the other plan contains all the specified food product that contains B-sitosterol compound. Then, B-sitosterol food enriched diet plan contains specified amount of this phytosterol (1.5-3g).
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 (T 1 ) | Placebo comparator | Dietary Supplement: Control group (T 1 )simple lipid control diet plan |
| Treatment Group (T 2 ) | Active comparator | Dietary Supplement: Treatment Group (T 2 )b-sitosterol food items diet plan |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 25-55 years
- Diagnosed with hyperlipidemia (LDL ≥ 130 mg/dL or Total Cholesterol ≥ 200 mg/dL)
- BMI between 35.0-39.9 kg/m²
- Willing to follow a prescribed diet plan for the entire study duration
Key exclusion criteria (4 listed)
- Patients with sitosterolemia, kidney or liver diseases
- Pregnant or lactating women
- Current use of statins, fibrates, or plant sterol supplements
- Individuals with food allergies to any prescribed ingredients
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 |
|---|---|---|
| Control group (T 1 )The control group (T0) received hyperlipidemia controlled diet plan | Dietary supplement | Control group (T 1 ) |
| Treatment Group (T 2 )the experimental group (T1) received b-sitosterol specified food products containing 2-3g/day. | Dietary supplement | Treatment Group (T 2 ) |
Primary outcome
Body Mass Index
Time frame: 8 weeks
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: 8 weeks
Blood lipid profile will be obtained using fasting blood samples to determine serum total cholesterol, high-density lipoprotein cholesterol (HD L-C), low density lipoprotein cholesterol (LDL-C) and triglycerides.
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 10 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Hyperlipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Hypercholesterolemia, Atherosclerosis
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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 Treatment Group (T 2 ) in people with Hyperlipidemia and Obese Individuals, 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 10 Jul 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: 8 weeks). 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 10 Jul 2026.