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The effect of Comvita propolis supplementation on markers of immune function in healthy adults.

Investigating the effect of acute and chronic Comvita propolis supplementation on immune cell function in healthy adults.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001247662
Enrollment
20
Registered
2023-12-01
Start date
2024-02-05
Completion date
2024-04-30
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Propolis have antimicrobial properties that have been associated with the high concentration of plant polyphenols within propolis. Plant polyphenols have been shown to attenuate inflammation, and population studies have identified that diets containing polyphenolic rich foods inversely correlates with the frequency and severity of various reported inflammatory condition symptoms. Propolis has been used by humans for centuries as a natural or “herbal” remedy, particularly for wound healing, as an antimicrobial agent, and to improve immune function. Propolis has been shown to inhibit free radical and nitric oxide production, inducible nitric oxide synthase (iNOS) protein; reduced secretion of interleukin (IL)-8, granulocyte colony-stimulating factor (GCSF) and granulocyte-macrophage colony-stimulating factor (GMCSF); and gene expression of cyclooxygenase (COX)-2, IL-1ß and IL-6 in vitro. These results suggest that propolis consumption could be beneficial in reducing inflammatory response in humans. Consistent with this a meta-analysis of six clinical studies found that propolis supplementation reduced serum C-reactive protein and TNFa concentration in adults compared with the control. In this study, we aim to determine the effect of acute and chronic supplementation with Comvita propolis on modulating the immune response of immune cells following cell activation with PMA:Ionomycin. We hypothesise that both acute and chronic supplementation with propolis will attenuate the inflammatory response of peripheral blood mononuclear immune cells following ex vivo stimulation with PMA:Ionomycin.

Interventions

The intervention is an over-the-counter available Comvita propolis product presented in the same gelatine capsule form. The propolis capsules contain cellulose-microcrystalline (bulking agent), propolis extract with 400 mg pure propolis, silicon dioxide, glyceryl monostearate and magnesium stearate (anticaking agents). Participants will be given a number of capsules at the beginning of the study arm to take home and required to consume a single capsule with water daily for six weeks. Particip

The intervention is an over-the-counter available Comvita propolis product presented in the same gelatine capsule form. The propolis capsules contain cellulose-microcrystalline (bulking agent), propolis extract with 400 mg pure propolis, silicon dioxide, glyceryl monostearate and magnesium stearate (anticaking agents). Participants will be given a number of capsules at the beginning of the study arm to take home and required to consume a single capsule with water daily for six weeks. Participants will be asked to return any capsules that they did not consume at the end of their supplementation period. Plasma samples collected at the beginning of each trial day will also be measured for specific polyphenols, enabling the detection of non-adherence to dietary restrictions within a minimum of 24 hours before their respective trial day.

Sponsors

Dr Jocelyn Eason
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Participants will be included if they have given written informed consent and are gauged as healthy by self report and their General Health Questionnaire. Participants will be included if their blood parameters do not indicate significant illness for albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea, calcium, chloride, creatinine, potassium, sodium, total bilirubin, total protein, glucose, HbA1c.

Exclusion criteria

Blood parameters for albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea, calcium, chloride, creatinine, potassium, sodium, total bilirubin, total protein, glucose and HBA1c being indicative of clinically significant illness. Participants will be excluded if they are unwilling to unable to provide written consent or comply with the study procedures. Participants will also be excluded if they have known hypersensitivity or intolerance to propolis bee stings and/or specific food additives. In addition, participants will be excluded if they are breastfeeding, pregnant, planning to get pregnant in the immediate future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) recent bacterial or viral illness or (iii) are taking medication that affects the properties of blood (e.g. blood clotting).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026