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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: 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 si Xweeks. 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. CONDITION: Immune function; ; Immune function Inflammatory and Immune System ‐ Normal development and function of the immune system PRIMARY OUTCOME: Composite cytokine production of ex‐vivo stimulated peripheral immune cells isolated from participants' peripheral blood.[Assayed using a bead‐based multiplex assay kit and measured by flow cytometry. Pre‐supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.] 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. SECONDARY OUTCOME: Comparison of epigenetic changes in immune cells following acute and long‐term propolis supplementation. This will be assessed as a composite outcome.[Immune cells will be cryopreserved and sent to commercial laboratories for epigenetic sequencing. Pre‐supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.] Comparison of transciptomic changes in immune cells following acute and long‐term propolis supplementation. This will be assessed as a composite outcome.[Immune cells will be cryopreserved and sent to commercial laboratories for transciptomic sequencing. Pre‐supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.] Composite measure of immune cell types and metabolism status.[Immune cell phenotyping and their metabolism status will be measured by antibody staining and parameters quantified by flow cytometry. Pre‐supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.] Composite subjective assessment of general health using validated questions.[Validated questionnaires and surveys including Daily Wellness Diary, Wisconsin Upper Respiratory Symptom Survey, Immune Status Questionnaire, MOS 36‐item short‐from health questionnaire, Pittsburgh sleep quality index, Short Form Profile of Mood States questionnaire and Bond Lader mood scales. The Daily Wellness Diary and Wisconsin Upper Respiratory Symptom Survey will be completed by participants daily from their location. Immune Status Questionnaire, MOS 36‐item short‐from health questionnaire, Pittsburgh sleep quality index, Short Form Profile of Mood States questionnaire and Bond Lader mood scales will be completed pre‐supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.] Propolis flavonoid bioavailability after consuming a single dose of propolis and after 6 weeks of daily supplementation[Measures using validated in‐house high performance liquid chromatography (HPLC) methods. Pre‐supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.]
Epistemonikos ID: 5959dca36f45451d0d4ab099a8d95ee4fa1f0959
First added on: Aug 26, 2024