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Completed

NCT Number: NCT05717881

Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

Propolis, a natural resinous mixture rich in polyphenols, produced by bees from a variety of plant sources, has shown significant therapeutic effects and may prevent the development of certain chronic diseases. Current evidence supports the beneficial effect of these bioactive phytochemicals on the management of type 2 diabetes mellitus (T2DM) and other chronic diseases. The objective of this study is to evaluate the effect of poplar propolis extract powder (PPEP) on glucose homeostasis and other clinical parameters in insulin-resistant patients (diagnosed by HOMA-IR index > 1.85 for men and > 2.07 for women).

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIC La conception

Marseille, France

About this study

Backgroud: Propolis, a natural resinous mixture rich in polyphenols, produced by bees from a variety of plant sources, has shown significant therapeutic effects and may prevent the development of certain chronic diseases. Current evidence supports the beneficial effect of these bioactive phytochemicals on the management of type 2 diabetes mellitus (T2DM) and other chronic diseases. The objective of this study is to evaluate the effect of poplar propolis extract powder (PPEP) on glucose homeostasis and other clinical parameters in insulin-resistant patients (diagnosed by HOMA-IR index > 1.85 for men and > 2.07 for women).

Methods: The trial was a randomized, controlled, crossover, intervention study. Insulin-resistant patients (n=9) (8 women, 1 man), with a mean ± SD age 49 ± 7, were subjected to two periods of supplementation (propolis and placebo) for 3-months, separated by a 2-week washout period. The quantity of propolis administered was determined individually to reach 6 mg of polyphenols/kg. Fasting blood test and oral glucose tolerance test (OGTT) were performed before and after each treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) ≥ 30 kg/m2
  • Insulin resistance defined as a HOMA-IR index > 1.85 for men and > 2.07 for women

Exclusion criteria

  • Presence of diabetes
  • Recent weight change (≥ 5% in the last 3 months)
  • Documented allergy to bee products and/or fish products
  • Positive serology for human immunodeficiency virus or hepatitis
  • High blood pressure
  • Elevated transaminases (AST > 40 IU/L ; ALT > 45 IU/L)
  • Low creatine clearance (estimated glomerular filtration rate < 90 ml/min)
  • Interfering treatment (cholesterol-lowering treatment, intestinal absorption modulating treatment, absorption modulating treatment and/or insulin sensitivity)
  • Gastrointestinal tract surgery
  • Pregnancy and / or lactation.

Treatment and study plan

Propolis

Dietary Supplement

Propolis supplements were packaged in marine capsules and consisted of poplar propolis powder (propolis concentrate, carob powder, magnesium stearate and silicon dioxide), concentrated to 30% total polyphenols.

Each supplementation period lasted 3 months, with a 2-week wash-out period, to allow total excretion of polyphenols by the body and do not interfere with the new supplementation phase.

The subjects in this study were submitted to five visits, allowing the tracking of biological parameters (clinical examination, fasting blood samples, HGPO) during the study. During the supplementation phases, follow-up by telephone call was performed.

Placebo

Dietary Supplement

Placebo powder capsules (maltodextrin, fatty acids, magnesium salts and silicon dioxide) are presented in the same packaging to have an identical appearance and taste. Patients in the propolis group were dosed with propolis to reach 6 mg total polyphenols/kg body weight, based on the results of a previous preclinical study in mice.

Each supplementation period lasted 3 months, with a 2-week wash-out period, to allow total excretion of polyphenols by the body and do not interfere with the new supplementation phase.

The subjects in this study were submitted to five visits, allowing the tracking of biological parameters (clinical examination, fasting blood samples, HGPO) during the study. During the supplementation phases, follow-up by telephone call was performed.

Primary outcomes

  1. Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M)

    Time frame: 3 months

    The primary outcome was change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M) at the end of supplementation. The ISI-M is calculated by the following formula: 10,000 / square root [(Glu0 × Ins0) × (Glumean OGTT × Insmean OGTT)], where Glux and Insx represent plasma glucose (mg/dL) and insulin values (UI/L), respectively, at time x min during. The ISI-M index, proposed by Matsuda and Defronzo, makes it possible to estimate insulin sensitivity derived from the OGTT

Secondary outcomes

  1. Change in glucose homeostasis

    Time frame: 3 months

    Glycaemia at T0, T30, T60, T90 and T120 (mmol/L) mesured after after an oral glucose tolerance test (OGTT).

  2. Change in insulin homeostasis

    Time frame: 3 months

    Insulinemia at T0, T30, T60, T90 and T120 (mUI/L) mesured after after an oral glucose tolerance test (OGTT).

  3. Change in triglyceride levels

    Time frame: 3 months

    Enzymatic assay by spectrophotometry of triglycerides (mmol/L).

  4. Change in cholesterol levels

    Time frame: 3 months

    Enzymatic assay by spectrophotometry of cholesterol (mmol/L).

  5. Change in high density lipoprotein (HDL) cholesterol levels

    Time frame: 3 months

    Enzymatic assay by spectrophotometry of HDL cholesterol (mmol/L).

  6. Change in low density lipoprotein (LDL) cholesterol levels

    Time frame: 3 months

    Friedewald formula : LDL=cholesterol-HDL-(triglyceride/2,2) expressed in mmol/L.

  7. Change in glycated hemoglobin A1c (HbA1c) levels

    Time frame: 3 months

    HbA1c mass spectrometry assay (%).

  8. Change in weight

    Time frame: 3 months

    Weight measurement by scale (kg).

  9. Change in body mass index (BMI)

    Time frame: 3 months

    BMI calculated by weight (kg) / size (m) squared.

  10. Change in body fat rate

    Time frame: 3 months

    Fat mass rate estimated by impedancemetry (DEXA) (%).

  11. Change in body lean rate

    Time frame: 3 months

    Lean mass rate estimated by impedancemetry (DEXA) (%).

  12. Change in C-reactive protein

    Time frame: 3 months

    Enzymatic determination of CRP (mg/L).

  13. Change in transaminases levels

    Time frame: 3 months

    Enzymatic determination of alanine aminotransferase (ALAT) and aspartate aminotransférase (ASAT) (UI/L).

  14. Change in gamma glutamyl transferases (GGT)

    Time frame: 3 months

    Enzymatic determination of gamma glutamyl transferases (GGT) (UI/L).

  15. Change in 8-iso-prostaglandin F2α levels

    Time frame: 3 months

    Enzymatic determination of 8-iso-prostaglandin F2α (8-iso-PGF 2α) (pg/mL).

  16. Change in creatinine levels

    Time frame: 3 months

    Enzymatic determination of creatinine (mg/L).

  17. Change in creatinine clearance

    Time frame: 3 months

    Estimation of creatinine clearance (mL/min) by formula : 1,23 (for men) or 1,04 (for women) x weight (kg) x (140 - age)/creatinine (mg/L).

  18. Change in leptin levels

    Time frame: 3 months

    Enzymatic determination of leptin (pg/mL).

  19. Change in adiponectin levels

    Time frame: 3 months

    Enzymatic determination of adiponectin (ng/mL).

Sponsors and collaborators

Lead sponsor

Aix Marseille Université

Other

Collaborators

  • Assistance Publique Hopitaux De Marseille

Registry information

Official study title

Impact of Poplar Propolis on Insulin Homeostasis and Pancreatic Cell Function in Insulin Resistant Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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