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The aim of the present clinical study is to estimate the efficacy of a honey-based gel, derived from the wider area of Pindos in Greece, in regulating oxidative stress biomarkers and the physiological profile of healthy adults.
Introduction: Honey contains about 200 compounds such as sugars, proteins, vitamins, water, free amino acids, enzymes, minerals, and many phytochemicals. Due to its composition, enriched with many bioactive ingredients, several studies have established its antimicrobial, antiviral, anticancer, antidiabetic and antioxidant properties. This multilayer activity of honey has been proposed for the protection against pathologies interrelated with the cardiovascular, nervous, respiratory, and gastrointestinal system.
Purpose: This study aims to investigate the effects of a novel natural honey-based gel consumption on oxidative stress biomarkers, blood chemistry and physiological characteristics in healthy individuals.
Methodology: A total of 20 healthy men and women will participate in the study. Participants will give their informed consent after they will be informed about the purposes, procedures, risks and benefits associated with the study. Participants will consume 70 g/day of the honey-based gel, distributed in 2 equal doses (in the morning and evening) for 14 days. At baseline and post-intervention, volunteers will be assessed for their physiological profile and will provide a resting blood sample for the assessment of oxidative stress and blood chemistry biomarkers as well as their physiological profile. Participants will be asked to record their diet for 3 days prior to the study and they will be asked to follow the same dietary pattern for 3 days before the post-intervention assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honey-based gel consumption | Experimental | A honey-based gel will be administered to participants in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey-based gel supplementation | Dietary Supplement | 70 g/day of a honey-based gel divided into 2 equal doses of 35 gr (in the morning and evening) for a total duration of 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glutathione concentration of erythrocytes | Glutathione concentration will be analyzed in erythrocytes by spectrophotometry | Change from baseline to 14 days |
| Change in catalase enzyme activity of erythrocytes | Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry | Change from baseline to 14 days |
| Change in total antioxidant capacity of plasma | Total antioxidant capacity will be analyzed in plasma by spectrophotometry | Change from baseline to 14 days |
| Change in thiobarbituric acid reactive substances of plasma | Thiobarbituric acid reactive substances will be analyzed in plasma by spectrophotometry | Change from baseline to 14 days |
| Change in protein carbonyls of plasma | Protein Carbonyls will be analyzed in plasma by spectrophotometry | Change from baseline to 14 days |
| Change in body weight | Body weight will be measured using a digital scale | Change from baseline to 14 days |
| Change in body fat | Body fat will be measured by bioelectrical impedance analysis | Change from baseline to 14 days |
| Change in resting heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athanasios Z. Jamurtas, Professor | University of Thessaly | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly | Trikala | Thessaly | 42150 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33435215 | Background | Mohd Kamal DA, Ibrahim SF, Kamal H, Kashim MIAM, Mokhtar MH. Physicochemical and Medicinal Properties of Tualang, Gelam and Kelulut Honeys: A Comprehensive Review. Nutrients. 2021 Jan 10;13(1):197. doi: 10.3390/nu13010197. | |
| 23411187 | Background | Escuredo O, Miguez M, Fernandez-Gonzalez M, Carmen Seijo M. Nutritional value and antioxidant activity of honeys produced in a European Atlantic area. Food Chem. 2013 Jun 1;138(2-3):851-6. doi: 10.1016/j.foodchem.2012.11.015. Epub 2012 Nov 17. |
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Resting heart rate will be measured using a heart rate sensor |
| Change from baseline to 14 days |
| Change in diastolic and systolic blood pressure | Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer | Change from baseline to 14 days |
| Change in waist and hip circumference | Waist and hip circumference will be assessed using a tape measure | Change from baseline to 14 days |
| Change in complete blood count | White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood | Change from baseline to 14 days |
| 12617614 | Background | Schramm DD, Karim M, Schrader HR, Holt RR, Cardetti M, Keen CL. Honey with high levels of antioxidants can provide protection to healthy human subjects. J Agric Food Chem. 2003 Mar 12;51(6):1732-5. doi: 10.1021/jf025928k. |