Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

Not Applicable

Completed

• Conditions: Insulin Resistance

• Registration Number: NCT05717881
• Lead Sponsor: Aix Marseille Université

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2020-06-02
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-10
• Study First Submitted: 2023-01-27
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-06
• Last Update Submitted: 2023-02-06
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M)	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 Outcome Measures

Name	Time	Method
Change in triglyceride levels	3 months	Enzymatic assay by spectrophotometry of triglycerides (mmol/L).
Change in cholesterol levels	3 months	Enzymatic assay by spectrophotometry of cholesterol (mmol/L).
Change in high density lipoprotein (HDL) cholesterol levels	3 months	Enzymatic assay by spectrophotometry of HDL cholesterol (mmol/L).
Change in weight	3 months	Weight measurement by scale (kg).
Change in C-reactive protein	3 months	Enzymatic determination of CRP (mg/L).
Change in transaminases levels	3 months	Enzymatic determination of alanine aminotransferase (ALAT) and aspartate aminotransférase (ASAT) (UI/L).
Change in gamma glutamyl transferases (GGT)	3 months	Enzymatic determination of gamma glutamyl transferases (GGT) (UI/L).
Change in creatinine clearance	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).
Change in glucose homeostasis	3 months	Glycaemia at T0, T30, T60, T90 and T120 (mmol/L) mesured after after an oral glucose tolerance test (OGTT).
Change in body mass index (BMI)	3 months	BMI calculated by weight (kg) / size (m) squared.
Change in body fat rate	3 months	Fat mass rate estimated by impedancemetry (DEXA) (%).
Change in creatinine levels	3 months	Enzymatic determination of creatinine (mg/L).
Change in adiponectin levels	3 months	Enzymatic determination of adiponectin (ng/mL).
Change in 8-iso-prostaglandin F2α levels	3 months	Enzymatic determination of 8-iso-prostaglandin F2α (8-iso-PGF 2α) (pg/mL).
Change in leptin levels	3 months	Enzymatic determination of leptin (pg/mL).
Change in insulin homeostasis	3 months	Insulinemia at T0, T30, T60, T90 and T120 (mUI/L) mesured after after an oral glucose tolerance test (OGTT).
Change in low density lipoprotein (LDL) cholesterol levels	3 months	Friedewald formula : LDL=cholesterol-HDL-(triglyceride/2,2) expressed in mmol/L.
Change in body lean rate	3 months	Lean mass rate estimated by impedancemetry (DEXA) (%).
Change in glycated hemoglobin A1c (HbA1c) levels	3 months	HbA1c mass spectrometry assay (%).

Trial Locations

Locations (1)

CIC La conception; 🇫🇷 Marseille, France