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Completed

NCT Number: NCT07696559

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

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

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Obese Individuals

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore

Lahore, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Effects of β-sitosterol -Enriched Dietary Intervention on Lipid Profile to Alleviate Hyperlipidemia Among Grade II Obese Individuals

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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