Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

Aix Marseille Université9 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Insulin Resistance

Interventions

PropolisDIETARY_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.

PlaceboDIETARY_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

CIC La conception

Marseille, France

Outcomes

Primary Outcomes

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

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

Time frame: 3 months

Secondary Outcomes

Change in glucose homeostasis

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

Time frame: 3 months

Change in insulin homeostasis

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

Time frame: 3 months

Change in triglyceride levels

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

Time frame: 3 months

Change in cholesterol levels

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

Time frame: 3 months

Change in high density lipoprotein (HDL) cholesterol levels

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

Time frame: 3 months

Change in low density lipoprotein (LDL) cholesterol levels

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

Data from ClinicalTrials.gov

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