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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07696559

Enrollment

Registered

2026-07-10

Start date

2026-01-15

Completion date

2026-04-15

Last updated

2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Obese Individuals

Keywords

lipid profile, obese grade II, Hyperlipedemia

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

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).

Interventions

DIETARY_SUPPLEMENTControl group (T 1 )

The control group (T0) received hyperlipidemia controlled diet plan

DIETARY_SUPPLEMENTTreatment Group (T 2 )

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Body Mass Index	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	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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026