Honey Consumption, Oxidative Stress and Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers

Conditions
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Oxidative Stress

Intervention / Treatment
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* Dietary Supplement: Honey-based gel supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Individuals aged 18-65 years Non-smokers Exclusion Criteria: Musculoskeletal injury Dietary supplements Medication Allergy in bee pollen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honey-based gel consumption<br>A honey-based gel will be administered to participants in this arm. | Dietary Supplement: Honey-based gel supplementation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative stress, Honey, Antioxidants, Health