Effect of Tahini in Oxidative Stress and Endothelial Function in Diabetes

February 27, 2024 updated by: PANAGIOTIS KANELLOS, Harokopio University

Effect of Tahini Consumption on Oxidative Stress and Inflammation Markers as Well as Endothelial Function and Arterial Stiffness in Patients With Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Panagiotis Kanellos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Collaborators

National and Kapodistrian University of Athens

Investigators

  • Study Director: NIKOLAOS K TENTOLOURIS, PROF, Diabetes Center, Medical School, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on tahini and bread

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe