Effect of Tahini in Oxidative Stress and Endothelial Function in Diabetes

Sponsor

Harokopio University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05396079

Collaborator

National and Kapodistrian University of Athens (Other)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

5.8

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.

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. Tahini is rich in polyunsaturated fatty acids, proteins, vitamin E and lignans, such as sesamin, sesamolin and sesamol. Recent studies have indicated that tahini consumption can lower blood pressure and pulse rate and improve endothelial function and glycemic response in healthy males postprandially.

However, only two studies are available in the current literature concerning the effect on diabetes, one of them in patients with type 2 diabetes and one in diabetic 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 patients with type 2 diabetes postprandially.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Endothelial Function Blood Pressure Arterial Stiffness Blood Glucose Diabetes Mellitus, Type 2	Other: tahini and bread Other: margarine, cheese and bread	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.

Regarding the consumption of tahini and its effect on human health, only a few studies are available in the current literature. The most recent of them have indicated that tahini consumption can lower blood pressure and pulse rate and improve endothelial function and glycemic response in healthy males postprandially. However, only two studies are available in the current literature concerning the effect on diabetes, one of them in patients with type 2 diabetes and one in diabetic 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 patients with type 2 diabetes postprandially.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover 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 Patients With Type 2 Diabetes

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tahini and bread After an overnight fast (10-12 h), participants will come tο the lab and, after a 10-min resting period in the supine position in a quiet room with temperature a constant 20-25 °C, assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be performed. Then, an intravenous cannula will be inserted into a forearm vein and a baseline blood sample will be collected (time 0) as well as urine sample will be also collected. Afterward, each patient will consume 2 slices of white bread with 50 g of tahini and collection of the blood and urine sample will be repeated 1,2, 3 and 4 h postprandially. Assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be also repeated at the end of the trial. During the trial, patients will not be allowed to eat or drink anything apart from water.	Other: tahini and bread Fifthy grams of tahini with 2 slices of white bread
Experimental: Margarine, cheese and bread After an overnight fast (10-12 h), participants will come tο the lab and, after a 10-min resting period in the supine position in a quiet room with temperature a constant 20-25 °C, assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be performed. Then, an intravenous cannula will be inserted into a forearm vein and a baseline blood sample will be collected (time 0) as well as urine sample will be also collected. Afterward, each patient will consume 2 slices of white bread with 46 g of margarine and 38 g of lowfat cheese and collection of the blood and urine sample will be repeated 1,2, 3 and 4 h postprandially. Assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be also repeated at the end of the trial. During the trial, patients will not be allowed to eat or drink anything apart from water.	Other: margarine, cheese and bread 46 g of margarine and 38 g of cheese with 2 slices of white bread

Arm

Intervention/Treatment

Experimental: Tahini and bread

After an overnight fast (10-12 h), participants will come tο the lab and, after a 10-min resting period in the supine position in a quiet room with temperature a constant 20-25 °C, assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be performed. Then, an intravenous cannula will be inserted into a forearm vein and a baseline blood sample will be collected (time 0) as well as urine sample will be also collected. Afterward, each patient will consume 2 slices of white bread with 50 g of tahini and collection of the blood and urine sample will be repeated 1,2, 3 and 4 h postprandially. Assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be also repeated at the end of the trial. During the trial, patients will not be allowed to eat or drink anything apart from water.

Other: tahini and bread

Fifthy grams of tahini with 2 slices of white bread

Experimental: Margarine, cheese and bread

After an overnight fast (10-12 h), participants will come tο the lab and, after a 10-min resting period in the supine position in a quiet room with temperature a constant 20-25 °C, assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be performed. Then, an intravenous cannula will be inserted into a forearm vein and a baseline blood sample will be collected (time 0) as well as urine sample will be also collected. Afterward, each patient will consume 2 slices of white bread with 46 g of margarine and 38 g of lowfat cheese and collection of the blood and urine sample will be repeated 1,2, 3 and 4 h postprandially. Assessment of blood pressure, pulse rate, hemodynamic parameters, and endothelial function will be also repeated at the end of the trial. During the trial, patients will not be allowed to eat or drink anything apart from water.

Other: margarine, cheese and bread

46 g of margarine and 38 g of cheese with 2 slices of white bread

Outcome Measures

Primary Outcome Measures

Concentration of urinary 8-iso-prostaglandin F2a [Four hours after consumption of both meals]
We will measure the concentration of urinary 8-iso-prostaglandin F2a by using Elisa kit
Assessment of Flow-Mediated Dilatation [Four hours after consumption of both meals]
We will assess the FMD by high-resolution ultrasound imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

minimum period from diagnosis three years
good glycemic control (HbA1c <7%)
taking a stable anti-diabetic treatment for the last 3 months (anti-diabetic tablets only)