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

NCT07696559 | Completed DMC

• 1 other identifier: IRB-UOL-FAHS/251/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyperlipidemia; Obese Individuals

Keywords

lipid profile; obese grade II; Hyperlipedemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 weeks

Study Arms (2)

Control group (T 1 )

PLACEBO COMPARATOR

simple lipid control diet plan

Dietary Supplement: Control group (T 1 )

Treatment Group (T 2 )

ACTIVE COMPARATOR

b-sitosterol food items diet plan

Dietary Supplement: Treatment Group (T 2 )

Interventions

Control group (T 1 ) DIETARY_SUPPLEMENT

The control group (T0) received hyperlipidemia controlled diet plan

Control group (T 1 )

Treatment Group (T 2 ) DIETARY_SUPPLEMENT

the experimental group (T1) received b-sitosterol specified food products containing 2-3g/day.

Treatment Group (T 2 )

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore

Lahore, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head University Institute of Diet and Nutritional Sciences

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: January 15, 2026
• Primary Completion: March 15, 2026
• Study Completion: April 15, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)