Blood Pressure Clinical Trial
Official title:
Effect of Tahini Consumption on Oxidative Stress and Inflammation Markers as Well as Endothelial Function and Arterial Stiffness in Healthy Volunteers
NCT number | NCT04608747 |
Other study ID # | 703 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2, 2020 |
Est. completion date | July 31, 2020 |
Verified date | October 2020 |
Source | Harokopio University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiovascular disease (CVD), a cluster of disorders that affect heart and blood vessels, is the leading cause of morbidity and mortality around the world and is responsible for 17.9 million deaths annually worldwide. CVD risk factors can be modifiable (nutrition, physical activity, obesity, smoking, hyperlipidemia, hypertension and diabetes) and non-modifiable (age, gender, ethnicity, family history and socioeconomic status). Chronic exposure to CVD risk factors induces oxidative stress and promotes inflammation. In addition, endothelial cells in response to the inflammatory reaction secrete growth factors, leading to the destruction of vascular endothelium and promoting atherogenesis. Oxidative stress refers to the imbalance between anti-oxidant and pro-oxidant compounds, with predominance of the pro-oxidant ones. Reactive Oxygen Species overproduction has been implicated in pathogenesis and complications of numerous diseases including diabetes, cardiovascular diseases, cancer, neurodegenerative diseases and chronic kidney disease. Moreover, endothelium consists of a single layer of endothelial cells; it is the natural barrier between blood and tissues and also an endocrine organ. It plays a key role in vascular homeostasis by maintaining a balance between vasodilation and vasoconstriction and is responsible for fluid filtration, blood vessel tone, hormone trafficking, hemostasis, regulation of blood flow and growth of blood vessels. Thus, reductions in endothelial function are detrimental and predict and precede the development of overt CVD. Sesame belongs to Pedaliaceae family and can be consumed in different forms such as seeds, oil or tahini, i.e., a 100 % peeled, ground and roasted sesame paste. Sesame seeds are rich in polyunsaturated fatty acids, proteins, vitamin E and lignans, such as sesamin, sesamolin and sesamol. Recent studies have highlighted the antioxidant, antihypertensive, hypolipidemic and appetite control properties of sesame seeds and sesame oil. Regarding the consumption of tahini and its effect on human health, only three studies are available in the current literature, one of them in patients with type 2 diabetes, one in diabetic animal model and one in Alzheimer's disease animal model. Thus, the aim of the present study is to investigate the effect of tahini consumption on oxidative stress, blood pressure, endothelial function and arterial stiffness in healthy males postprandially.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - age between 20 and 40 years - Body Mass Index (BMI)<30 kg/m2 Exclusion Criteria: - alcohol or drug abuse, - any medication or vitamin/mineral supplementation - alternative diet (vegetarian, macrobiotic, etc.) - recent use of antibiotics - history of any chronic disease |
Country | Name | City | State |
---|---|---|---|
Greece | Diabetes Center, First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Harokopio University |
Greece,
Alipoor B, Haghighian MK, Sadat BE, Asghari M. Effect of sesame seed on lipid profile and redox status in hyperlipidemic patients. Int J Food Sci Nutr. 2012 Sep;63(6):674-8. doi: 10.3109/09637486.2011.652077. Epub 2012 Jan 23. — View Citation
Birben E, Sahiner UM, Sackesen C, Erzurum S, Kalayci O. Oxidative stress and antioxidant defense. World Allergy Organ J. 2012 Jan;5(1):9-19. doi: 10.1097/WOX.0b013e3182439613. Epub 2012 Jan 13. — View Citation
Gouveia Lde A, Cardoso CA, de Oliveira GM, Rosa G, Moreira AS. Effects of the Intake of Sesame Seeds (Sesamum indicum L.) and Derivatives on Oxidative Stress: A Systematic Review. J Med Food. 2016 Apr;19(4):337-45. doi: 10.1089/jmf.2015.0075. Review. — View Citation
Hirata F, Fujita K, Ishikura Y, Hosoda K, Ishikawa T, Nakamura H. Hypocholesterolemic effect of sesame lignan in humans. Atherosclerosis. 1996 Apr 26;122(1):135-36. — View Citation
Kamal-Eldin A, Frank J, Razdan A, Tengblad S, Basu S, Vessby B. Effects of dietary phenolic compounds on tocopherol, cholesterol, and fatty acids in rats. Lipids. 2000 Apr;35(4):427-35. — View Citation
Karatzi K, Stamatelopoulos K, Lykka M, Mantzouratou P, Skalidi S, Zakopoulos N, Papamichael C, Sidossis LS. Sesame oil consumption exerts a beneficial effect on endothelial function in hypertensive men. Eur J Prev Cardiol. 2013 Apr;20(2):202-8. doi: 10.1177/2047487312437625. Epub 2012 Jan 25. — View Citation
Khalesi S, Paukste E, Nikbakht E, Khosravi-Boroujeni H. Sesame fractions and lipid profiles: a systematic review and meta-analysis of controlled trials. Br J Nutr. 2016 Mar 14;115(5):764-73. doi: 10.1017/S0007114515005012. Epub 2016 Jan 13. Review. — View Citation
Khosravi-Boroujeni H, Nikbakht E, Natanelov E, Khalesi S. Can sesame consumption improve blood pressure? A systematic review and meta-analysis of controlled trials. J Sci Food Agric. 2017 Aug;97(10):3087-3094. doi: 10.1002/jsfa.8361. Epub 2017 May 12. Review. — View Citation
Krüger-Genge A, Blocki A, Franke RP, Jung F. Vascular Endothelial Cell Biology: An Update. Int J Mol Sci. 2019 Sep 7;20(18). pii: E4411. doi: 10.3390/ijms20184411. Review. — View Citation
Kumar, S., & Pandey, A. (2015). Free Radicals: Health Implications and their Mitigation by Herbals. British Journal Of Medicine And Medical Research, 7(6), 438-457. doi: 10.9734/bjmmr/2015/16284
Namiki M. Nutraceutical functions of sesame: a review. Crit Rev Food Sci Nutr. 2007;47(7):651-73. Review. — View Citation
Neves Ribeiro D, Gonçalves Alfenas Rde C, Bressan J, Brunoro Costa NM. The effect of oilseed consumption on appetite and on the risk of developing type 2 diabetes mellitus. Nutr Hosp. 2013 Mar-Apr;28(2):296-305. doi: 10.3305/nh.2013.28.2.6309. Review. — View Citation
Park KH, Park WJ. Endothelial Dysfunction: Clinical Implications in Cardiovascular Disease and Therapeutic Approaches. J Korean Med Sci. 2015 Sep;30(9):1213-25. doi: 10.3346/jkms.2015.30.9.1213. Epub 2015 Aug 13. Review. — View Citation
Pathak N, Rai AK, Kumari R, Bhat KV. Value addition in sesame: A perspective on bioactive components for enhancing utility and profitability. Pharmacogn Rev. 2014 Jul;8(16):147-55. doi: 10.4103/0973-7847.134249. Review. — View Citation
Phaniendra A, Jestadi DB, Periyasamy L. Free radicals: properties, sources, targets, and their implication in various diseases. Indian J Clin Biochem. 2015 Jan;30(1):11-26. doi: 10.1007/s12291-014-0446-0. Epub 2014 Jul 15. Review. — View Citation
Raeisi-Dehkordi, H., Mohammadi, M., Moghtaderi, F., & Salehi-Abargouei, A. (2018). Do sesame seed and its products affect body weight and composition? A systematic review and meta-analysis of controlled clinical trials. Journal Of Functional Foods, 49, 324-332. doi: 10.1016/j.jff.2018.08.036
Rajendran P, Rengarajan T, Thangavel J, Nishigaki Y, Sakthisekaran D, Sethi G, Nishigaki I. The vascular endothelium and human diseases. Int J Biol Sci. 2013 Nov 9;9(10):1057-69. doi: 10.7150/ijbs.7502. eCollection 2013. Review. — View Citation
Ravarotto V, Simioni F, Pagnin E, Davis PA, Calò LA. Oxidative stress - chronic kidney disease - cardiovascular disease: A vicious circle. Life Sci. 2018 Oct 1;210:125-131. doi: 10.1016/j.lfs.2018.08.067. Epub 2018 Aug 31. Review. — View Citation
Sies H. Oxidative stress: a concept in redox biology and medicine. Redox Biol. 2015;4:180-3. doi: 10.1016/j.redox.2015.01.002. Epub 2015 Jan 3. Review. — View Citation
Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29. — View Citation
Willcox JK, Ash SL, Catignani GL. Antioxidants and prevention of chronic disease. Crit Rev Food Sci Nutr. 2004;44(4):275-95. Review. — View Citation
Wu WH, Kang YP, Wang NH, Jou HJ, Wang TA. Sesame ingestion affects sex hormones, antioxidant status, and blood lipids in postmenopausal women. J Nutr. 2006 May;136(5):1270-5. — View Citation
Zoumpoulakis, P., Sinanoglou, V., Batrinou, A., Strati, I., Miniadis-Meimaroglou, S., & Sflomos, K. (2012). A combined methodology to detect ?-irradiated white sesame seeds and evaluate the effects on fat content, physicochemical properties and protein allergenicity. Food Chemistry, 131(2), 713-721. doi: 10.1016/j.foodchem.2011.09.049
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of oxidative stress biomarkers | concentration of urinary 8-iso-prostaglandin F2a | Four hours after tahini consumption |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
Completed |
NCT05997303 -
Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT03918486 -
Caretaker vs. Routine Blood Pressure Sphygmomanometer
|
||
Completed |
NCT03410342 -
The Effects of Types of Fruits and Vegetables on Vascular Function
|
N/A | |
Active, not recruiting |
NCT05062161 -
Sleep Duration and Blood Pressure During Sleep
|
N/A | |
Not yet recruiting |
NCT04087070 -
Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
|
||
Completed |
NCT03294928 -
Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers
|
N/A | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Completed |
NCT03997461 -
Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device
|
N/A | |
Completed |
NCT03290716 -
Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China
|
N/A | |
Recruiting |
NCT05196048 -
Blood Pressure Sensor of Watch-type Device With ECG Technology
|
||
Recruiting |
NCT06460233 -
Blood Pressure Changes After Bariatric Surgery
|
||
Terminated |
NCT03325933 -
Resistance Training and Cardiometabolic Health
|
N/A | |
Not yet recruiting |
NCT06405880 -
Pharmacist Case Finding and Intervention for Vascular Prevention Trial
|
N/A | |
Completed |
NCT02924454 -
Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.
|
Phase 4 | |
Completed |
NCT02451059 -
Reducing Socioeconomic Disparities in Health at Pediatric Visits
|
N/A | |
Active, not recruiting |
NCT02670967 -
Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials
|
N/A | |
Completed |
NCT02239744 -
Intervention Study on the Health Impact of Air Filters in Chinese Adults
|
N/A | |
Completed |
NCT02271633 -
Nitrate Supplementation; Source
|
Phase 4 |