Tahini, Antioxidant Status and Endothelial Function

Sponsor

Harokopio University (Other)

Overall Status

Completed

CT.gov ID

NCT04608747

Collaborator

(none)

Enrollment

Location

Arm

6.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Endothelial Function Blood Pressure Arterial Stiffness Blood Glucose	Other: Tahini	N/A

Detailed Description

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 includes coronary heart disease, peripheral arterial disease, cerebrovascular disease, rheumatic heart disease, congenital heart disease, deep vein thrombosis and pulmonary embolism. 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. These compounds are also called Reactive Oxygen Species (ROS) or free radicals and are unstable atoms or molecules. Their generation, as products of normal cellular metabolism, occurs naturally by endogenous sources (e.g. mitochondria, peroxisomes and endoplasmic reticulum) through enzymatic and non-enzymatic reactions. Furthermore, exogenous sources implicated in free radical production are air pollution, alcohol consumption, tobacco smoking, ultraviolet light exposure, industrial solvents and others. Free radical production is regulated by the well-organized human endogenous enzymatic and non-enzymatic antioxidant system, along with the exogenous antioxidants found in food. However, in some cases antioxidant system fails to eliminate ROS overproduction and can consequently induce serious damage to important for life biomolecules (DNA, lipids, proteins), leading to cell injury and death. Thus, ROS 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. Moreover, vascular endothelium 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 (PUFAs), 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. Moreover, few studies have investigated the effect of sesame consumption on blood pressure, endothelial function and arterial stiffness in human population. According to a metanalysis, sesame consumed in form of seed, oil, capsule or bar decreased both systolic blood pressure (SBP) and diastolic blood pressure (DBP), while sesame oil consumption was found to improve endothelial function both in the postprandial state and after long term consumption in hypertensive men.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effect of Tahini Consumption on Oxidative Stress and Inflammation Markers as Well as Endothelial Function and Arterial Stiffness in Healthy Volunteers

Actual Study Start Date :

Jan 2, 2020

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm After an overnight fast, participants subjected to baseline measurements and blood and urine collection and then consumed an amount of 50 g of tahini. Blood and urine collection and other measurements were repeated 4 h postprandially.	Other: Tahini Fifty grams of tahini were consumed by 20 healthy males

Arm

Intervention/Treatment

Experimental: Intervention arm

After an overnight fast, participants subjected to baseline measurements and blood and urine collection and then consumed an amount of 50 g of tahini. Blood and urine collection and other measurements were repeated 4 h postprandially.

Other: Tahini

Fifty grams of tahini were consumed by 20 healthy males

Outcome Measures

Primary Outcome Measures

Concentration of oxidative stress biomarkers [Four hours after tahini consumption]
concentration of urinary 8-iso-prostaglandin F2a

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Center, First Department of Propaedeutic Internal Medicine, Medical School, National and Kapodistrian University of Athens, Laiko General Hospital	Athens		Greece	11527

Sponsors and Collaborators

Harokopio University

Investigators

Study Director: NIKOLAOS K TENTOLOURIS, PROF, Diabetes CeMedical School, National and Kapodistrian University of Athens, Laiko General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

PANAGIOTIS KANELLOS, POSTDOCTORAL RESEARCHER, Harokopio University

ClinicalTrials.gov Identifier:

NCT04608747

Other Study ID Numbers:

First Posted:

Oct 29, 2020

Last Update Posted:

Oct 30, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by PANAGIOTIS KANELLOS, POSTDOCTORAL RESEARCHER, Harokopio University

Study Results

No Results Posted as of Oct 30, 2020