Honey Consumption, Oxidative Stress and Health

Sponsor
University of Thessaly (Other)
Overall Status
Recruiting
CT.gov ID
NCT05756842
Collaborator
(none)
20
1
1
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2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Honey-based gel supplementation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers
Actual Study Start Date :
Mar 6, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Honey-based gel consumption

A honey-based gel will be administered to participants in this arm.

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

Outcome Measures

Primary Outcome Measures

  1. Change in glutathione concentration of erythrocytes [Change from baseline to 14 days]

    Glutathione concentration will be analyzed in erythrocytes by spectrophotometry

  2. Change in catalase enzyme activity of erythrocytes [Change from baseline to 14 days]

    Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry

  3. Change in total antioxidant capacity of plasma [Change from baseline to 14 days]

    Total antioxidant capacity will be analyzed in plasma by spectrophotometry

  4. Change in thiobarbituric acid reactive substances of plasma [Change from baseline to 14 days]

    Thiobarbituric acid reactive substances will be analyzed in plasma by spectrophotometry

  5. Change in protein carbonyls of plasma [Change from baseline to 14 days]

    Protein Carbonyls will be analyzed in plasma by spectrophotometry

  6. Change in body weight [Change from baseline to 14 days]

    Body weight will be measured using a digital scale

  7. Change in body fat [Change from baseline to 14 days]

    Body fat will be measured by bioelectrical impedance analysis

  8. Change in resting heart rate [Change from baseline to 14 days]

    Resting heart rate will be measured using a heart rate sensor

  9. Change in diastolic and systolic blood pressure [Change from baseline to 14 days]

    Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer

  10. Change in waist and hip circumference [Change from baseline to 14 days]

    Waist and hip circumference will be assessed using a tape measure

  11. Change in complete blood count [Change from baseline to 14 days]

    White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy Individuals aged 18-65 years

  • Non-smokers

Exclusion Criteria:
  • Musculoskeletal injury

  • Dietary supplements

  • Medication

  • Allergy in bee pollen

Contacts and Locations

Locations

Site City State Country Postal Code
1 Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly Trikala Thessaly Greece 42150

Sponsors and Collaborators

  • University of Thessaly

Investigators

  • Study Director: Athanasios Z. Jamurtas, Professor, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Athanasios Z. Jamurtas, Professor, University of Thessaly
ClinicalTrials.gov Identifier:
NCT05756842
Other Study ID Numbers:
  • UTH-HoneyGel
First Posted:
Mar 6, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Athanasios Z. Jamurtas, Professor, University of Thessaly

Study Results

No Results Posted as of Mar 8, 2023