Nigella Sativa Supplementation in Hyperlipidemia Treatment

NCT06890546 | Completed

• 1 other identifier: NSHYPERLIPIDEMIA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperlipidemia is defined as an elevation of plasma cholesterol, lipid, or lipoprotein levels above normal due to abnormal fat metabolism or function, and individuals with hyperlipidemia are approximately twice as likely to develop cardiovascular disease. The first approach to treating hyperlipidemia is lifestyle changes, including dietary therapy and physical activity. In addition to traditional methods, treatments also include pharmacological interventions, and research on natural products and complementary therapies is increasing to increase the effectiveness of these treatment approaches. In this context, Nigella Sativa (NS) oil has emerged as a promising natural option in the treatment of hyperlipidemia and obesity in recent years. The aim of this study was to examine the effects of NS oil supplementation given together with dietary intervention in individuals diagnosed with mild obesity. The main questions it aims to answer are:

• Does Nigella Sativa supplementation improve blood lipid profiles in overweight or obese individuals?
• Does Nigella Sativa supplementation improve body composition in overweight or obese individuals? Participants were individuals who were diagnosed with hyperlipidemia according to American Heart Association criteria as a result of medical evaluation by a cardiologist and who were deemed appropriate to use black seed oil supplements. Those who volunteered to participate in the study were included in the study. The researchers are examining whether there is any effect on biochemical and anthropometric parameters by giving Nigella Sativa supplementation to a group in addition to a low-calorie diet for eight weeks.

Conditions

Hyperlipidaemia; Hyperlipidemia

Keywords

Nigella sativa; Obesity; medical nutrition therapy

Outcome Measures

Primary Outcomes (17)

• Biochemical Measurements - fasting blood glucose

  fasting blood glucose (mg/dL) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning and end of the study from blood samples taken by a nurse

  8 weeks

• Biochemical Measurement

  Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning and end of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.

  8 weeks

• Biochemical Measurements - Liver Enzymes

  Participants' liver enzymes tests (ALT and AST) (IU) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning and end of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.

  8 weeks

• Anthropometric Measurements - Body weight (kg)

  At the beginning and end of the study, body weights (kg) were measured using a bioelectrical impedance (BIA) device (Tanita Perfecto) with a sensitivity of 50 grams in accordance with the measurement standards.

  8 weeks

• Anthropometric Measurements - Height

  Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.

  8 weeks

• Body Mass Index

  The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.

  8 weeks

• Body Mass Index Classification

  The body mass index (BMI) of the participants was classified according to the World Health Organization (WHO) criteria. BMI ≥ 25 kg/m2 was overweight and ≥ 30 kg/m2 was obese.

  8 weeks

• Anthropometric Measurements - Fat Mass

  Body fat mass (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.

  8 weeks

• Anthropometric Measurements - Fat ratio calculation

  At the beginning and end of the study, body composition analyses were performed using a bioelectrical impedance (BIA) device (Tanita Perfecto) with the measurement standards. According to the BIA analysis, fat ratio (%) was calculated as the ratio of total body fat weight to total body weight as a percentage.

  8 weeks

• Anthropometric Measurements - Fat-free mass

  Fat-free mass (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.

  8 weeks

• Anthropometric Measurements - Muscle mass

  Muscle mass (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.

  8 weeks

• Anthropometric Measurements - Total body water

  Total body water (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.

  8 weeks

• Anthropometric Measurements - Waist circumference

  At the beginning and end of the study, waist circumference were measured with a non-flexible tape measure at the midpoint between the lowest rib bone and the cristailiac crest.

  8 weeks

• Anthropometric Measurements - Hip circumference

  At the beginning and end of the study, in measuring hip circumference, the individual was asked to stand upright with their arms at their sides and their feet side by side. Frankfort plane was provided. The individual stood on their right side. The highest point on the hip (from the side) was determined and the circumference was measured with a tape measure.

  8 weeks

• Anthropometric Measurements - Neck circumference

  At the beginning and end of the study, neck circumference measurement was made with a tape measure just below the laryngeal prominence (Adam's apple).

  8 weeks

• Anthropometric Measurements - Waist/Height Ratio

  At the beginning and end of the study, waist/height ratio was obtained by dividing waist circumference by height.

  8 weeks

• Anthropometric Measurements - Waist/Hip Ratio

  Waist/hip ratio was obtained by dividing waist circumference by hip circumference.

  8 weeks

Secondary Outcomes (1)

• Physical Activity

  1 week

Study Arms (2)

Nigella Sativa Group

EXPERIMENTAL

Nigella Sativa oil supplement and low calorie diet intervention

Dietary Supplement: Nigella Sativa Oil capsule; Behavioral: Diet

Control Group

PLACEBO COMPARATOR

low calorie diet intervention

Behavioral: Diet

Interventions

Nigella Sativa Oil capsule DIETARY_SUPPLEMENT

8 weeks 2 x 900 mg Nigella Sativa oil capsule daily

Nigella Sativa Group

Diet BEHAVIORAL

Low calorie diet intervention

Control Group; Nigella Sativa Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults individuals who were diagnosed hyperlipidemia
• Individuals suitable for taking Nigella satvia supplement
• Individuals BMI\>25 kg/m2

You may not qualify if:

• Chronic liver disease,
• Chronic kidney disease,
• Heart failure, infarction or cerebrovascular disease,
• Pregnant and breastfeeding women,
• Severe psychiatric disorders,
• Oncological diseases,
• Individuals using medications that could interact with black seed oil (anticoagulant, antihypertensive, etc.)
• Individuals using antilipidemic or anticholesterolemic medications
• Individuals did not do heavy exercise
• Individuals using any nutritional supplement
• Individuals have a known history of allergy
• Individuals did not consume alcohol regularly
• Individuals with special dietary needs

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

İstanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

Related Publications (21)

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MeSH Terms

Conditions

Hyperlipidemias; Obesity

Interventions

Nigella sativa oil; Diet

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Hande Seven Avuk, PhD

  İstanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition and Dietetics Department

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 24, 2025
• Study Start: June 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)