HyperlipidaemiaNCT06890546
Nigella Sativa Supplementation in Hyperlipidemia Treatment
A study testing Nigella Sativa Oil capsule and Diet in people with Hyperlipidaemia and Hyperlipidemia, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperlipidaemia, Hyperlipidemia
- What is being tested?
- Nigella Sativa Oil capsule and Diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults individuals who were diagnosed hyperlipidemia
- Individuals suitable for taking Nigella satvia supplement
- Individuals BMI>25 kg/m2
Who cannot join
- Chronic liver disease,
- Chronic kidney disease,
- Heart failure, infarction or cerebrovascular disease,
- Pregnant and breastfeeding women,
- Severe psychiatric disorders,
- Oncological diseases,
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nigella Sativa Oil Supplementation and Dietary Intervention on Lipid Profile in Overweight Adults with Hyperlipidemia: a Randomized Controlled Clinical Trial
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.
Read more
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.
Read the detailed description
This research, which is a randomized controlled intervention study, was conducted between June 2023 and February 2024 with adult individuals with a BMI>25 kg/m2 who applied to the Cardiology Polyclinic of Karamürsel State Hospital and were referred to a nutrition and diet specialist after being diagnosed with hyperlipidemia according to AHA criteria by the physician.
Sample Selection and Randomization The sample size of the study was calculated using the G-Power 3.1.9 analysis program with a medium effect size (d=0.60), 90% power, α: 0.05 and 1-β: 0.95, with a minimum of 32 people in each group, 64 people were included. The 64 people who met the inclusion criteria were assigned to the intervention (n=32) and control (n=32) groups using the block randomization method, with similar age and gender.
Inclusion Criteria from the Study Individuals who were diagnosed with hyperlipidemia between the ages of 18-65, who did not have any serious comorbidities (kidney, liver and immune deficiency, oncological and psychiatric diseases), who were not pregnant or breastfeeding, who did not take any nutritional supplements including black seed, who did not have a known history of allergy to black seed and its products, who did not use medications that could interact with black seed oil (anticoagulant, antihypertensive, etc.), who did not use antilipidemic or anticholesterolemic medications, who did not do heavy exercise, who did not consume alcohol regularly and who did not have any special diet requirements were included in the study.
Data Collection Tools Research data were recorded using a questionnaire form, anthropometric measurements, biochemical tests and the IPAQ form.
Survey Form: Sociodemographic information, smoking and nutritional habits of the participants were recorded in the survey form.
Anthropometric Measurements: At the beginning and end of the study, body weights and analyses were performed using a bioelectrical impedance (BIA) device (Tanita Perfecto) with a sensitivity of 50 grams in accordance with the measurement standards. According to the BIA analysis, fat ratio (%), fat mass, fat-free mass, muscle mass and total body water were evaluated. At the beginning and end of the study, waist, hip and neck circumferences were measured with a non-stretchable tape measure, paying attention to anthropometric measurement standards. Waist/height and waist/hip values were calculated. Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright. The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula and classified according to the World Health Organization (WHO) criteria.
International Physical Activity Questionnaire Short Form (IPAQ): IPAQ-Short form, developed by Craig et al. and whose Turkish validity and reliability study was conducted by Öztürk, was used to assess the physical activity levels of the participants. Physical activity levels were classified as light, moderate and vigorous active.
Biochemical Tests: Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting blood glucose, ALT and AST) 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.
Research Plan In this study, 64 hyperlipidemic individuals with BMI>25 kg/m2 were divided into 2 groups as control (n=32 individuals) and intervention (n=32 individuals). The control group was given a low-fat, low-cholesterol weight loss diet specific to the individual for 8 weeks, while the intervention group (n=32) was given a similar diet along with 2x900 mg black seed oil in softgels. Questions regarding the participants' sociodemographic characteristics, smoking, alcohol consumption and physical activity habits were recorded on a questionnaire form through face-to-face interviews. Participants attended face-to-face dietician control interviews every two weeks to observe compliance with the nutrition programs throughout the study.
Diet Plan: While determining the daily energy needs of the participants, the resting metabolic rate was calculated with the Mifflin-St.Jeor formula. The physical activity levels of the individuals were determined using the IPAQ-Short Form. The thermic effect of the nutrients was taken as 10% and the total daily energy requirement was calculated. In order for the participants to lose weight, 500 calories were subtracted from the total energy requirement. A nutrition program was given in accordance with the diet recommendations created by the American Heart Association (AHA) for hyperlipidemic individuals.
Black seed oil: In this study, black seed oil in the form of 900 mg softgels was administered orally to the intervention group at a dose of 2x900 mg. Black seed oil obtained by the cold-pressing method (TAB İlaç Sanayi A.Ş., Esenyurt, İstanbul) is in softgel form. The product is a licensed supplement with the TR-34-K-210340 certificate by the Turkish Standards Institute (TSE) and the Food Supplement Approval Number 003683-21.12.2017 of the Ministry of Agriculture and Forestry. Some studies investigating the effects of black seed oil on hyperlipidemia and other health problems show that 1-2 g of black seed or 500-1000 mg of black seed oil per day may be effective. These doses are usually taken in two divided doses daily. Moreover, a daily therapeutic dose of 2000 mg N.S has been considered safe in previous studies. Human and animal models showed no serious side effects or toxicological effects caused by the plant. The black seed oil capsules given to the participants were provided by the researcher.
- Conditions
- Hyperlipidaemia, Hyperlipidemia
- Being tested
- Nigella Sativa Oil capsule, Diet
- Keywords
- Nigella sativa, Obesity, medical nutrition therapy
- Medical subject headings
- Hyperlipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella Sativa Oil capsuleDietary supplement
8 weeks 2 x 900 mg Nigella Sativa oil capsule daily
DietBehavioural
Low calorie diet intervention
| Study group | Role | What they receive |
|---|---|---|
| Nigella Sativa Group | Experimental | Nigella Sativa oil supplement and low calorie diet intervention Receives: Dietary Supplement: Nigella Sativa Oil capsule; Behavioral: Diet |
| Control Group | Placebo comparator | low calorie diet intervention Receives: Behavioral: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Anthropometric Measurements - Height
Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 8 weeks
Anthropometric Measurements - Waist/Hip Ratio
Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
Measured: 8 weeks
Secondary outcomes (1)
Physical Activity
International Physical Activity Questionnaire Short Form developed by Craig et al. and whose Turkish validity and reliability study was conducted by Öztürk, was used to assess the physical activity levels of the participants. Physical activity levels were classified as light, moderate and vigorous active.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jun 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for HyperlipidaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Seven Avuk, Istanbul Bilgi University
- Investigators
- Hande Seven Avuk, PhD, Principal investigator, İstanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890546
- Sponsor's protocol ID
- NSHYPERLIPIDEMIA
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adanir SS, Kervancioglu P, Bahsi I, Al Saadi M, Van de Heyning P, Topsakal V. Anatomical investigation of safety determining factors for keyhole drilling trajectories for robotic cochlear implant surgery. Eur Arch Otorhinolaryngol. 2025 Jun;282(6):3037-3050. doi: 10.1007/s00405-024-09198-4. Epub 2025 Jan 17.
PubMed 39825202Mifflin MD, St Jeor ST, Hill LA, Scott BJ, Daugherty SA, Koh YO. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990 Feb;51(2):241-7. doi: 10.1093/ajcn/51.2.241.
PubMed 2305711Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Norgan NG. Laboratory and field measurements of body composition. Public Health Nutr. 2005 Oct;8(7A):1108-22. doi: 10.1079/phn2005799.
PubMed 16277823Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
PubMed 29386200Al Asoom L. Is Nigella sativa an Effective Bodyweight Lowering Agent and a Mitigator of Obesity Risk? A Literature Review. Vasc Health Risk Manag. 2022 Jul 12;18:495-505. doi: 10.2147/VHRM.S373702. eCollection 2022.
PubMed 35855753Sahebkar A, Beccuti G, Simental-Mendia LE, Nobili V, Bo S. Nigella sativa (black seed) effects on plasma lipid concentrations in humans: A systematic review and meta-analysis of randomized placebo-controlled trials. Pharmacol Res. 2016 Apr;106:37-50. doi: 10.1016/j.phrs.2016.02.008. Epub 2016 Feb 10.
PubMed 26875640Rounagh M, Musazadeh V, Hosseininejad-Mohebati A, Falahatzadeh M, Kavyani Z, Rostami RB, Vajdi M. Effects of Nigella sativa supplementation on lipid profiles in adults: An updated systematic review and meta-analysis of randomized controlled trials. Clin Nutr ESPEN. 2024 Jun;61:168-180. doi: 10.1016/j.clnesp.2024.03.020. Epub 2024 Mar 22.
PubMed 38777430Lichtenstein AH, Appel LJ, Vadiveloo M, Hu FB, Kris-Etherton PM, Rebholz CM, Sacks FM, Thorndike AN, Van Horn L, Wylie-Rosett J. 2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific Statement From the American Heart Association. Circulation. 2021 Dec 7;144(23):e472-e487. doi: 10.1161/CIR.0000000000001031. Epub 2021 Nov 2.
PubMed 34724806Karr S. Epidemiology and management of hyperlipidemia. Am J Manag Care. 2017 Jun;23(9 Suppl):S139-S148.
PubMed 28978219Kaatabi H, Bamosa AO, Lebda FM, Al Elq AH, Al-Sultan AI. Favorable impact of Nigella sativa seeds on lipid profile in type 2 diabetic patients. J Family Community Med. 2012 Sep;19(3):155-61. doi: 10.4103/2230-8229.102311.
PubMed 23230380Razmpoosh E, Safi S, Nadjarzadeh A, Fallahzadeh H, Abdollahi N, Mazaheri M, Nazari M, Salehi-Abargouei A. The effect of Nigella sativa supplementation on cardiovascular risk factors in obese and overweight women: a crossover, double-blind, placebo-controlled randomized clinical trial. Eur J Nutr. 2021 Jun;60(4):1863-1874. doi: 10.1007/s00394-020-02374-2. Epub 2020 Sep 2.
PubMed 32876804Ibrahim RM, Hamdan NS, Mahmud R, Imam MU, Saini SM, Rashid SN, Abd Ghafar SA, Latiff LA, Ismail M. A randomised controlled trial on hypolipidemic effects of Nigella Sativa seeds powder in menopausal women. J Transl Med. 2014 Mar 31;12:82. doi: 10.1186/1479-5876-12-82.
PubMed 24685020Ahmad A, Husain A, Mujeeb M, Khan SA, Najmi AK, Siddique NA, Damanhouri ZA, Anwar F. A review on therapeutic potential of Nigella sativa: A miracle herb. Asian Pac J Trop Biomed. 2013 May;3(5):337-52. doi: 10.1016/S2221-1691(13)60075-1.
PubMed 23646296
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nigella Sativa Oil Supplementation and Dietary Intervention on Lipid Profile in Overweight Adults with Hyperlipidemia: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06890546
- Acronym / sponsor ID
- NSHYPERLIPIDEMIA
- Conditions
- Hyperlipidaemia, Hyperlipidemia
- Keywords
- Nigella sativa, Obesity, medical nutrition therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research, which is a randomized controlled intervention study, was conducted between June 2023 and February 2024 with adult individuals with a BMI>25 kg/m2 who applied to the Cardiology Polyclinic of Karamürsel State Hospital and were referred to a nutrition and diet specialist after being diagnosed with hyperlipidemia according to AHA criteria by the physician.
Sample Selection and Randomization The sample size of the study was calculated using the G-Power 3.1.9 analysis program with a medium effect size (d=0.60), 90% power, α: 0.05 and 1-β: 0.95, with a minimum of 32 people in each group, 64 people were included. The 64 people who met the inclusion criteria were assigned to the intervention (n=32) and control (n=32) groups using the block randomization method, with similar age and gender.
Inclusion Criteria from the Study Individuals who were diagnosed with hyperlipidemia between the ages of 18-65, who did not have any serious comorbidities (kidney, liver and immune deficiency, oncological and psychiatric diseases), who were not pregnant or breastfeeding, who did not take any nutritional supplements including black seed, who did not have a known history of allergy to black seed and its products, who did not use medications that could interact with black seed oil (anticoagulant, antihypertensive, etc.), who did not use antilipidemic or anticholesterolemic medications, who did not do heavy exercise, who did not consume alcohol regularly and who did not have any special diet requirements were included in the study.
Data Collection Tools Research data were recorded using a questionnaire form, anthropometric measurements, biochemical tests and the IPAQ form.
Survey Form: Sociodemographic information, smoking and nutritional habits of the participants were recorded in the survey form.
Anthropometric Measurements: At the beginning and end of the study, body weights and analyses were performed using a bioelectrical impedance (BIA) device (Tanita Perfecto) with a sensitivity of 50 grams in accordance with the measurement standards. According to the BIA analysis, fat ratio (%), fat mass, fat-free mass, muscle mass and total body water were evaluated. At the beginning and end of the study, waist, hip and neck circumferences were measured with a non-stretchable tape measure, paying attention to anthropometric measurement standards. Waist/height and waist/hip values were calculated. Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright. The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula and classified according to the World Health Organization (WHO) criteria.
International Physical Activity Questionnaire Short Form (IPAQ): IPAQ-Short form, developed by Craig et al. and whose Turkish validity and reliability study was conducted by Öztürk, was used to assess the physical activity levels of the participants. Physical activity levels were classified as light, moderate and vigorous active.
Biochemical Tests: Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting blood glucose, ALT and AST) 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.
Research Plan In this study, 64 hyperlipidemic individuals with BMI>25 kg/m2 were divided into 2 groups as control (n=32 individuals) and intervention (n=32 individuals). The control group was given a low-fat, low-cholesterol weight loss diet specific to the individual for 8 weeks, while the intervention group (n=32) was given a similar diet along with 2x900 mg black seed oil in softgels. Questions regarding the participants' sociodemographic characteristics, smoking, alcohol consumption and physical activity habits were recorded on a questionnaire form through face-to-face interviews. Participants attended face-to-face dietician control interviews every two weeks to observe compliance with the nutrition programs throughout the study.
Diet Plan: While determining the daily energy needs of the participants, the resting metabolic rate was calculated with the Mifflin-St.Jeor formula. The physical activity levels of the individuals were determined using the IPAQ-Short Form. The thermic effect of the nutrients was taken as 10% and the total daily energy requirement was calculated. In order for the participants to lose weight, 500 calories were subtracted from the total energy requirement. A nutrition program was given in accordance with the diet recommendations created by the American Heart Association (AHA) for hyperlipidemic individuals.
Black seed oil: In this study, black seed oil in the form of 900 mg softgels was administered orally to the intervention group at a dose of 2x900 mg. Black seed oil obtained by the cold-pressing method (TAB İlaç Sanayi A.Ş., Esenyurt, İstanbul) is in softgel form. The product is a licensed supplement with the TR-34-K-210340 certificate by the Turkish Standards Institute (TSE) and the Food Supplement Approval Number 003683-21.12.2017 of the Ministry of Agriculture and Forestry. Some studies investigating the effects of black seed oil on hyperlipidemia and other health problems show that 1-2 g of black seed or 500-1000 mg of black seed oil per day may be effective. These doses are usually taken in two divided doses daily. Moreover, a daily therapeutic dose of 2000 mg N.S has been considered safe in previous studies. Human and animal models showed no serious side effects or toxicological effects caused by the plant. The black seed oil capsules given to the participants were provided by the researcher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nigella Sativa Group | Experimental | Dietary Supplement: Nigella Sativa Oil capsule, Behavioral: DietNigella Sativa oil supplement and low calorie diet intervention |
| Control Group | Placebo comparator | Behavioral: Dietlow calorie diet intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults individuals who were diagnosed hyperlipidemia
- Individuals suitable for taking Nigella satvia supplement
- Individuals BMI>25 kg/m2
Key exclusion criteria (13 listed)
- Chronic liver disease,
- Chronic kidney disease,
- Heart failure, infarction or cerebrovascular disease,
- Pregnant and breastfeeding women,
- Severe psychiatric disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nigella Sativa Oil capsule8 weeks 2 x 900 mg Nigella Sativa oil capsule daily | Dietary supplement | Nigella Sativa Group |
| DietLow calorie diet intervention | Behavioural | Control Group, Nigella Sativa Group |
Primary outcome
Biochemical Measurements - fasting blood glucose
Time frame: 8 weeks
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
Biochemical Measurement
Time frame: 8 weeks
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.
Biochemical Measurements - Liver Enzymes
Time frame: 8 weeks
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.
Anthropometric Measurements - Body weight (kg)
Time frame: 8 weeks
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.
Anthropometric Measurements - Height
Time frame: 8 weeks
Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Body Mass Index
Time frame: 8 weeks
The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Body Mass Index Classification
Time frame: 8 weeks
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.
Anthropometric Measurements - Fat Mass
Time frame: 8 weeks
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.
Anthropometric Measurements - Fat ratio calculation
Time frame: 8 weeks
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.
Anthropometric Measurements - Fat-free mass
Time frame: 8 weeks
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.
Anthropometric Measurements - Muscle mass
Time frame: 8 weeks
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.
Anthropometric Measurements - Total body water
Time frame: 8 weeks
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.
Anthropometric Measurements - Waist circumference
Time frame: 8 weeks
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.
Anthropometric Measurements - Hip circumference
Time frame: 8 weeks
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.
Anthropometric Measurements - Neck circumference
Time frame: 8 weeks
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).
Anthropometric Measurements - Waist/Height Ratio
Time frame: 8 weeks
At the beginning and end of the study, waist/height ratio was obtained by dividing waist circumference by height.
Anthropometric Measurements - Waist/Hip Ratio
Time frame: 8 weeks
Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
1 secondary outcome
Physical Activity
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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- Background: PubMed 16277823Norgan NG. Laboratory and field measurements of body composition. Public Health Nutr. 2005 Oct;8(7A):1108-22. doi: 10.1079/phn2005799.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 29386200Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
- Background: PubMed 35855753Al Asoom L. Is Nigella sativa an Effective Bodyweight Lowering Agent and a Mitigator of Obesity Risk? A Literature Review. Vasc Health Risk Manag. 2022 Jul 12;18:495-505. doi: 10.2147/VHRM.S373702. eCollection 2022.
- Background: PubMed 26875640Sahebkar A, Beccuti G, Simental-Mendia LE, Nobili V, Bo S. Nigella sativa (black seed) effects on plasma lipid concentrations in humans: A systematic review and meta-analysis of randomized placebo-controlled trials. Pharmacol Res. 2016 Apr;106:37-50. doi: 10.1016/j.phrs.2016.02.008. Epub 2016 Feb 10.
- Background: PubMed 38777430Rounagh M, Musazadeh V, Hosseininejad-Mohebati A, Falahatzadeh M, Kavyani Z, Rostami RB, Vajdi M. Effects of Nigella sativa supplementation on lipid profiles in adults: An updated systematic review and meta-analysis of randomized controlled trials. Clin Nutr ESPEN. 2024 Jun;61:168-180. doi: 10.1016/j.clnesp.2024.03.020. Epub 2024 Mar 22.
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- Background: PubMed 23230380Kaatabi H, Bamosa AO, Lebda FM, Al Elq AH, Al-Sultan AI. Favorable impact of Nigella sativa seeds on lipid profile in type 2 diabetic patients. J Family Community Med. 2012 Sep;19(3):155-61. doi: 10.4103/2230-8229.102311.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hande Seven Avuk, PhD principal investigator
İstanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella Sativa Oil capsule and Diet in people with Hyperlipidaemia and Hyperlipidemia, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Measurements - fasting blood glucose (time frame: 8 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890546, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.