Effect of Tahini in Oxidative Stress and Endothelial Function in Diabetes

NCT05396079 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Endothelial Function; Blood Pressure; Arterial Stiffness; Blood Glucose; Diabetes Mellitus, Type 2

Keywords

tahini; sesame; antioxidants; postprandial

Outcome Measures

Primary Outcomes (2)

• Concentration of urinary 8-iso-prostaglandin F2a

  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

  We will assess the FMD by high-resolution ultrasound imaging

  Four hours after consumption of both meals

Study Arms (2)

Tahini and bread

EXPERIMENTAL

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

Margarine, cheese and bread

EXPERIMENTAL

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

Interventions

tahini and bread OTHER

Fifthy grams of tahini with 2 slices of white bread

Tahini and bread

margarine, cheese and bread OTHER

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

Margarine, cheese and bread

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Panagiotis Kanellos

Athens, Greece

Location

Related Publications (25)

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• Sakketou EI, Baxevanis GK, Tentolouris NK, Konstantonis GD, Karathanos VT, Fragkiadakis GA, Kanellos PT. Tahini consumption affects blood pressure and endothelial function in healthy males. J Hum Hypertens. 2022 Dec;36(12):1128-1132. doi: 10.1038/s41371-021-00624-2. Epub 2021 Oct 27.

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• Baxevanis, G.K., Sakketou, EK.I., Tentolouris, N.K. et al. Tahini consumption improves metabolic and antioxidant status biomarkers in the postprandial state in healthy males. Eur Food Res Technol 247, 2721-2728 (2021). https://doi.org/10.1007/s00217-021-03828-5

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; SeSAME syndrome

Interventions

Bread; Margarine; Cheese

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats; Fats; Lipids; Dairy Products; Cultured Milk Products; Milk; Beverages; Fermented Foods

Study Officials

• NIKOLAOS K TENTOLOURIS, PROF

  Diabetes Center, Medical School, National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 31, 2022
• Study Start: March 28, 2023
• Primary Completion: June 15, 2023
• Study Completion: September 15, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)