Effect of Bergamot and Plant Sterols Extract on Serum Lipid Profile

NCT06929403 | Completed

• 1 other identifier: BERGAMIAPLANTSTEROLSTUDY
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The consumption of 2 grams of plant sterols per day has been demonstrated to positively affect total cholesterol and low density lipoprotein (LDL) cholesterol, as supported by various clinical guidelines. These compounds do not exhibit any adverse side effects. The European Society of Cardiology's Dyslipidemia Guidelines indicate that among lifestyle modifications aimed at reducing total cholesterol and LDL, the consumption of functional foods enriched with phytosterols should be included as a high-level recommendation. Bergamot is a citrus fruit rich in flavonoids. Research on bergamot fruit extract has indicated its ability to lower total cholesterol, LDL cholesterol, and triglyceride levels while increasing high density lipoprotein(HDL) cholesterol levels. Furthermore, evidence suggests that it may help reduce high serum uric acid levels, which can pose a risk for cardiovascular diseases. The flavonoids in bergamot fruit extract contribute to the reduction of cholesterol synthesis in the liver. Additionally, it has a high capacity to prevent LDL oxidation. A study on individuals with metabolic syndrome observed significant and sustained reductions in serum cholesterol, triglyceride levels, and glucose in those consuming bergamot. This effect was accompanied by significant improvements in vascular reactivity in patients with hyperlipidemia and elevated serum glucose levels. Bergamot also exhibits the ability to inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Due to their structural similarity to cholesterol, plant sterols help block the intestinal absorption of dietary cholesterol. They provide benefits at the absorption level and increase cholesterol excretion via bile and fecal pathways. The existence of known side effects associated with cholesterol-lowering medications, such as statins- including muscle cramps, myopathy, increased risk of muscle toxicity, liver damage, and neuropathy-has created a need for complementary or alternative approaches to treating dyslipidemia. This research will consider the potential of both plant sterols and bergamot as dietary supplements. While cholesterol-lowering diets assist in reducing LDL, glucose, total cholesterol, and triglyceride levels, they do not enhance HDL levels. Because bergamot is known to increase HDL, it could provide an additional benefit in lipid profile regulation. A meta-analysis that studied various phytochemical supplements found that bergamot was the most effective in reducing total cholesterol, LDL, and triglyceride levels while increasing HDL levels. This study examines the effects of dietary supplementation containing plant sterols and bergamot on blood lipid profiles.

Conditions

Dyslipidemia; Cardiac Disease; Cardiovascular Diseases

Keywords

dyslipidemia; hyperlipidemia; plant sterols; Bergamot; complementary therapy

Outcome Measures

Primary Outcomes (18)

• Biochemical Measurements - Fasting blood glucose

  Fasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning and end of the study.

  12 weeks

• Biochemical Measurement - Lipid Profile

  Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) will be 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.

  12 weeks

• Biochemical Measurements - Liver Enzymes

  Participants' liver enzymes tests (ALT and AST) (IU) will be 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.

  12 weeks

• Biochemical Measurements - CRP

  Participants' c-reactive protein tests (CRP) (mg/L) will be 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.

  12 weeks

• Biochemical Measurements - Uric Acid Levels

  Participants' serum uric acid tests (mg/dL) will be 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.

  12 weeks

• Anthropometric Measurements - Body weight (kg)

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

  12 weeks

• Anthropometric Measurements - Height

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

  1 week

• Body Mass Index

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

  12 weeks

• Body Mass Index Classification

  The body mass index (BMI) of the participants is classified according to the World Health Organization (WHO) criteria. BMI ≤ 18.5 kg/m2 is underweight, between 18.5-24.99 kg/m2 is normal, ≥ 25 kg/m2 is overweight, and ≥ 30 kg/m2 is obese.

  12 weeks

• Anthropometric Measurements - Fat Mass

  At the beginning and end of the study, body fat mass (kg) analysis will be performed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  12 weeks

• Anthropometric Measurements - Fat ratio calculation

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

  12 weeks

• Anthropometric Measurements - Fat-free mass

  At the beginning and end of the study, fat-free mass (kg) will be analyzed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  12 weeks

• Anthropometric Measurements - Muscle mass

  At the beginning and end of the study, lean muscle mass (kg) will be analyzed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  12 weeks

• Anthropometric Measurements - Total body water

  At the beginning and end of the study, total body water (kg) will be analyzed using a bioelectrical impedance (BIA) device, paying attention to measurement standards.

  12 weeks

• Anthropometric Measurements - Waist circumference

  At the beginning and end of the study, waist circumference will be measured with a non-flexible tape measure at the midpoint between the lowest rib and the crystalline prominence.

  12 weeks

• Anthropometric Measurements - Hip circumference

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

  12 weeks

• Anthropometric Measurements - Waist/Height Ratio

  Waist/height ratio will be obtained by dividing waist circumference by height at the beginning and end of the study.

  12 weeks

• Anthropometric Measurements - Waist/Hip Ratio

  Waist/hip ratio will be obtained by dividing waist circumference by hip circumference.

  12 weeks

Secondary Outcomes (5)

• Physical Activity Levels

  1 week

• Food Consumption Record

  3 days

• Food Consumption Record

  3 days

• Food Consumption Record

  3 days

• Food Consumption Record

  3 days

Study Arms (3)

Diet Group

ACTIVE COMPARATOR

Low-fat, low-cholesterol heart-protective diet

Behavioral: Diet

Supplement Group

EXPERIMENTAL

Plant sterol/stanol supplement with bergamot

Dietary Supplement: Diet supplementation

Diet and Supplement Group

EXPERIMENTAL

Plant sterol/stanol supplement with bergamot and Low-fat, low-cholesterol heart-protective diet

Behavioral: Diet; Dietary Supplement: Diet supplementation

Interventions

Diet BEHAVIORAL

Low-fat, low-cholesterol heart-protective diet

Also known as: Low-fat, low-cholesterol heart-protective diet

Diet Group; Diet and Supplement Group

Diet supplementation DIETARY_SUPPLEMENT

2 tablets/daily bergamot and plant sterol/stanol supplement (375 mg bergamot fruit extract, 800 mg plant sterols and 150 mg flavonoids) for 12 weeks

Diet and Supplement Group; Supplement 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 supplement

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,
• People using medications that may interact with black seed oil (anticoagulant, antihypertensive, etc.)
• People using antilipidemic or anticholesterolemic medications in the last 3 months
• People with citrus allergies
• People who do not do heavy exercise
• People using any dietary supplements
• People with a known history of allergies
• People who do not regularly consume alcohol
• People with special dietary requirements

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

İstanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

• Norgan NG. Laboratory and field measurements of body composition. Public Health Nutr. 2005 Oct;8(7A):1108-22. doi: 10.1079/phn2005799.

  PMID: 16277823 BACKGROUND

• Craig 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.

  PMID: 12900694 BACKGROUND

• Faul 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.

  PMID: 17695343 BACKGROUND

• Guasch-Ferre M, Babio N, Martinez-Gonzalez MA, Corella D, Ros E, Martin-Pelaez S, Estruch R, Aros F, Gomez-Gracia E, Fiol M, Santos-Lozano JM, Serra-Majem L, Bullo M, Toledo E, Barragan R, Fito M, Gea A, Salas-Salvado J; PREDIMED Study Investigators. Dietary fat intake and risk of cardiovascular disease and all-cause mortality in a population at high risk of cardiovascular disease. Am J Clin Nutr. 2015 Dec;102(6):1563-73. doi: 10.3945/ajcn.115.116046. Epub 2015 Nov 11.

  PMID: 26561617 BACKGROUND

• Osadnik T, Golawski M, Lewandowski P, Morze J, Osadnik K, Pawlas N, Lejawa M, Jakubiak GK, Mazur A, Schwingschackl L, Gasior M, Banach M. A network meta-analysis on the comparative effect of nutraceuticals on lipid profile in adults. Pharmacol Res. 2022 Sep;183:106402. doi: 10.1016/j.phrs.2022.106402. Epub 2022 Aug 18.

  PMID: 35988871 BACKGROUND

• Racette SB, Lin X, Lefevre M, Spearie CA, Most MM, Ma L, Ostlund RE Jr. Dose effects of dietary phytosterols on cholesterol metabolism: a controlled feeding study. Am J Clin Nutr. 2010 Jan;91(1):32-8. doi: 10.3945/ajcn.2009.28070. Epub 2009 Nov 4.

  PMID: 19889819 BACKGROUND

• Ferro Y, Maurotti S, Mazza E, Pujia R, Sciacqua A, Musolino V, Mollace V, Pujia A, Montalcini T. Citrus Bergamia and Cynara Cardunculus Reduce Serum Uric Acid in Individuals with Non-Alcoholic Fatty Liver Disease. Medicina (Kaunas). 2022 Nov 26;58(12):1728. doi: 10.3390/medicina58121728.

  PMID: 36556930 BACKGROUND

• Gliozzi M, Walker R, Muscoli S, Vitale C, Gratteri S, Carresi C, Musolino V, Russo V, Janda E, Ragusa S, Aloe A, Palma E, Muscoli C, Romeo F, Mollace V. Bergamot polyphenolic fraction enhances rosuvastatin-induced effect on LDL-cholesterol, LOX-1 expression and protein kinase B phosphorylation in patients with hyperlipidemia. Int J Cardiol. 2013 Dec 10;170(2):140-5. doi: 10.1016/j.ijcard.2013.08.125. Epub 2013 Sep 8.

  PMID: 24239156 BACKGROUND

• Toth PP, Patti AM, Nikolic D, Giglio RV, Castellino G, Biancucci T, Geraci F, David S, Montalto G, Rizvi A, Rizzo M. Bergamot Reduces Plasma Lipids, Atherogenic Small Dense LDL, and Subclinical Atherosclerosis in Subjects with Moderate Hypercholesterolemia: A 6 Months Prospective Study. Front Pharmacol. 2016 Jan 6;6:299. doi: 10.3389/fphar.2015.00299. eCollection 2015.

  PMID: 26779019 BACKGROUND

• Gylling H, Plat J, Turley S, Ginsberg HN, Ellegard L, Jessup W, Jones PJ, Lutjohann D, Maerz W, Masana L, Silbernagel G, Staels B, Boren J, Catapano AL, De Backer G, Deanfield J, Descamps OS, Kovanen PT, Riccardi G, Tokgozoglu L, Chapman MJ; European Atherosclerosis Society Consensus Panel on Phytosterols. Plant sterols and plant stanols in the management of dyslipidaemia and prevention of cardiovascular disease. Atherosclerosis. 2014 Feb;232(2):346-60. doi: 10.1016/j.atherosclerosis.2013.11.043. Epub 2013 Nov 23.

  PMID: 24468148 BACKGROUND

• Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27. No abstract available.

  PMID: 27567407 BACKGROUND

• Expert Dyslipidemia Panel of the International Atherosclerosis Society Panel members. An International Atherosclerosis Society Position Paper: global recommendations for the management of dyslipidemia--full report. J Clin Lipidol. 2014 Jan-Feb;8(1):29-60. doi: 10.1016/j.jacl.2013.12.005. Epub 2013 Dec 17.

  PMID: 24528685 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias; Heart Diseases; Cardiovascular Diseases; Hyperlipidemias

Interventions

Diet; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hande Seven Avuk

  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: Assistant Professor, Head of Nutrition and Dietetic Department

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 16, 2025
• Study Start: January 4, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)