Clinical trial NCT05756842: Honey Consumption, Oxidative Stress and Health
Official title: The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxidative Stress
Keywords: Oxidative stress
Honey
Antioxidants
Health
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Healthy Individuals aged 18-65 years
* Non-smokers

Exclusion Criteria:

* Musculoskeletal injury
* Dietary supplements
* Medication
* Allergy in bee pollen

Primary outcomes:
measure: Change in glutathione concentration of erythrocytes
timeFrame: Change from baseline to 14 days
measure: Change in catalase enzyme activity of erythrocytes
timeFrame: Change from baseline to 14 days
measure: Change in total antioxidant capacity of plasma
timeFrame: Change from baseline to 14 days
measure: Change in thiobarbituric acid reactive substances of plasma
timeFrame: Change from baseline to 14 days
measure: Change in protein carbonyls of plasma
timeFrame: Change from baseline to 14 days
measure: Change in body weight
timeFrame: Change from baseline to 14 days
measure: Change in body fat
timeFrame: Change from baseline to 14 days
measure: Change in resting heart rate
timeFrame: Change from baseline to 14 days
measure: Change in diastolic and systolic blood pressure
timeFrame: Change from baseline to 14 days
measure: Change in waist and hip circumference
timeFrame: Change from baseline to 14 days
measure: Change in complete blood count
timeFrame: Change from baseline to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Athanasios Z. Jamurtas, Professor
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.