Oxidative StressNCT05756842
Honey Consumption, Oxidative Stress and Health
A study testing Honey-based gel supplementation in people with Oxidative Stress, run by University of Thessaly at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Honey-based gel supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- 6 Mar 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Individuals aged 18-65 years
- Non-smokers
Who cannot join
- Musculoskeletal injury
- Dietary supplements
- Medication
- Allergy in bee pollen
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly
Trikala, Thessaly, 42150
About this study
Official title: The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers
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.
Read the 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.
- Conditions
- Oxidative Stress
- Being tested
- Honey-based gel supplementation
- Keywords
- Oxidative stress, Honey, Antioxidants, Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey-based gel supplementationDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Honey-based gel consumption | Experimental | A honey-based gel will be administered to participants in this arm. Receives: Dietary Supplement: Honey-based gel supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glutathione concentration of erythrocytes
Glutathione concentration will be analyzed in erythrocytes by spectrophotometry
Measured: Change from baseline to 14 days
Change in catalase enzyme activity of erythrocytes
Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry
Measured: Change from baseline to 14 days
Change in total antioxidant capacity of plasma
Total antioxidant capacity will be analyzed in plasma by spectrophotometry
Measured: 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
Measured: Change from baseline to 14 days
Change in protein carbonyls of plasma
Protein Carbonyls will be analyzed in plasma by spectrophotometry
Measured: Change from baseline to 14 days
Change in body weight
Body weight will be measured using a digital scale
Measured: Change from baseline to 14 days
Change in body fat
Body fat will be measured by bioelectrical impedance analysis
Measured: Change from baseline to 14 days
Change in resting heart rate
Resting heart rate will be measured using a heart rate sensor
Measured: 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
Measured: Change from baseline to 14 days
Change in waist and hip circumference
Waist and hip circumference will be assessed using a tape measure
Measured: 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
Measured: Change from baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start6 Mar 2023
- Primary completion25 May 2023
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios Z. Jamurtas, University of Thessaly
- Investigators
- Athanasios Z. Jamurtas, Professor, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756842
- Sponsor's protocol ID
- UTH-HoneyGel
- Status last verified
- May 2023
- First submitted
- 18 Feb 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33435215Escuredo 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.
PubMed 23411187Schramm 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.
PubMed 12617614
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers
- ClinicalTrials.gov ID
- NCT05756842
- Acronym / sponsor ID
- UTH-HoneyGel
- Conditions
- Oxidative Stress
- Keywords
- Oxidative stress, Honey, Antioxidants, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Honey-based gel consumption | Experimental | Dietary Supplement: Honey-based gel supplementationA honey-based gel will be administered to participants in this arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Individuals aged 18-65 years
- Non-smokers
Key exclusion criteria (4 listed)
- Musculoskeletal injury
- Dietary supplements
- Medication
- Allergy in bee pollen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey-based gel supplementation70 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 | Dietary supplement | Honey-based gel consumption |
Primary outcome
Change in glutathione concentration of erythrocytes
Time frame: Change from baseline to 14 days
Glutathione concentration will be analyzed in erythrocytes by spectrophotometry
Change in catalase enzyme activity of erythrocytes
Time frame: Change from baseline to 14 days
Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry
Change in total antioxidant capacity of plasma
Time frame: Change from baseline to 14 days
Total antioxidant capacity will be analyzed in plasma by spectrophotometry
Change in thiobarbituric acid reactive substances of plasma
Time frame: Change from baseline to 14 days
Thiobarbituric acid reactive substances will be analyzed in plasma by spectrophotometry
Change in protein carbonyls of plasma
Time frame: Change from baseline to 14 days
Protein Carbonyls will be analyzed in plasma by spectrophotometry
Change in body weight
Time frame: Change from baseline to 14 days
Body weight will be measured using a digital scale
Change in body fat
Time frame: Change from baseline to 14 days
Body fat will be measured by bioelectrical impedance analysis
Change in resting heart rate
Time frame: Change from baseline to 14 days
Resting heart rate will be measured using a heart rate sensor
Change in diastolic and systolic blood pressure
Time frame: Change from baseline to 14 days
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Change in waist and hip circumference
Time frame: Change from baseline to 14 days
Waist and hip circumference will be assessed using a tape measure
Change in complete blood count
Time frame: Change from baseline to 14 days
White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Background: PubMed 33435215Mohd 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.
- Background: PubMed 23411187Escuredo 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.
- Background: PubMed 12617614Schramm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athanasios Z. Jamurtas, Professor study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey-based gel supplementation in people with Oxidative Stress, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glutathione concentration of erythrocytes (time frame: Change from baseline to 14 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756842, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.