Honey Consumption, Oxidative Stress and Health

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05756842
• Other study ID #: UTH-HoneyGel
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy Individuals aged 18-65 years

• Non-smokers

Exclusion Criteria:

• Musculoskeletal injury

• Dietary supplements

• Medication

• Allergy in bee pollen

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• Honey-based gel supplementation
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

Locations

Country	Name	City	State
Greece	Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly	Trikala	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glutathione concentration of erythrocytes	Glutathione concentration will be analyzed in erythrocytes by spectrophotometry	Change from baseline to 14 days
Primary	Change in catalase enzyme activity of erythrocytes	Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry	Change from baseline to 14 days
Primary	Change in total antioxidant capacity of plasma	Total antioxidant capacity will be analyzed in plasma by spectrophotometry	Change from baseline to 14 days
Primary	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
Primary	Change in protein carbonyls of plasma	Protein Carbonyls will be analyzed in plasma by spectrophotometry	Change from baseline to 14 days
Primary	Change in body weight	Body weight will be measured using a digital scale	Change from baseline to 14 days
Primary	Change in body fat	Body fat will be measured by bioelectrical impedance analysis	Change from baseline to 14 days
Primary	Change in resting heart rate	Resting heart rate will be measured using a heart rate sensor	Change from baseline to 14 days
Primary	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
Primary	Change in waist and hip circumference	Waist and hip circumference will be assessed using a tape measure	Change from baseline to 14 days
Primary	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