Effect of the β-sitosterol-enriched Dietary Plan on Lipid Levels.

July 6, 2026 updated by: Maria Aslam, University of Lahore

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • The University of Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group (T 1 )
simple lipid control diet plan
Dietary supplement: Control group (T 1 )
The control group (T0) received hyperlipidemia controlled diet plan
Active Comparator: Treatment Group (T 2 )
b-sitosterol food items diet plan
Dietary supplement: Treatment Group (T 2 )
the experimental group (T1) received b-sitosterol specified food products containing 2-3g/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Actual)

March 15, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-UOL-FAHS/251/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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