NCT05756842

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

February 18, 2023

Last Update Submit

May 27, 2023

Conditions

Oxidative Stress

Keywords

Oxidative stressHoneyAntioxidantsHealth

Outcome Measures

Primary Outcomes (11)

  • 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

Study Arms (1)

Honey-based gel consumption

EXPERIMENTAL

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

Dietary Supplement: Honey-based gel supplementation

Interventions

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

Honey-based gel consumption

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Biochemistry, Physiology and Nutrition Laboratory, Department of Physical Education and Sport Science, University of Thessaly

Trikala, Thessaly, 42150, Greece

Location

Related Publications (3)

  • 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.

    PMID: 33435215BACKGROUND

  • 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.

    PMID: 23411187BACKGROUND

  • 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.

    PMID: 12617614BACKGROUND

Study Officials

  • Athanasios Z. Jamurtas, Professor

    University of Thessaly

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 6, 2023

Study Start

March 6, 2023

Primary Completion

May 25, 2023

Study Completion

December 1, 2023

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)