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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
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
Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
Trikala, Thessaly, Greece
Change in glutathione concentration of erythrocytes
Glutathione concentration will be analyzed in erythrocytes by spectrophotometry
Time frame: Change from baseline to 14 days
Change in catalase enzyme activity of erythrocytes
Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry
Time frame: Change from baseline to 14 days
Change in total antioxidant capacity of plasma
Total antioxidant capacity will be analyzed in plasma by spectrophotometry
Time frame: 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
Time frame: Change from baseline to 14 days
Change in protein carbonyls of plasma
Protein Carbonyls will be analyzed in plasma by spectrophotometry
Time frame: Change from baseline to 14 days
Change in body weight
Body weight will be measured using a digital scale
Time frame: Change from baseline to 14 days
Change in body fat
Body fat will be measured by bioelectrical impedance analysis
Time frame: Change from baseline to 14 days
Change in resting heart rate
Resting heart rate will be measured using a heart rate sensor
Time frame: Change from baseline to 14 days
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Change in diastolic and systolic blood pressure
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Time frame: Change from baseline to 14 days
Change in waist and hip circumference
Waist and hip circumference will be assessed using a tape measure
Time frame: 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
Time frame: Change from baseline to 14 days