Clinical trial NCT05717881: Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance
Official title: Impact of Poplar Propolis on Insulin Homeostasis and Pancreatic Cell Function in Insulin Resistant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Propolis
Lead sponsor: Aix Marseille Université
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
First posted: 2023-02-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The present trial was a randomized, double-bind, controlled, crossover, dietary intervention study. During this trial, two types of supplementations were randomly administered during two treatment periods (propolis and placebo), using a random number table. The placebo served as the reference group for comparison. Participants and caregivers were blinded to the type of treatment consumed.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M)
timeFrame: 3 months
Secondary outcomes:
measure: Change in glucose homeostasis
timeFrame: 3 months
measure: Change in insulin homeostasis
timeFrame: 3 months
measure: Change in triglyceride levels
timeFrame: 3 months
measure: Change in cholesterol levels
timeFrame: 3 months
measure: Change in high density lipoprotein (HDL) cholesterol levels
timeFrame: 3 months
measure: Change in low density lipoprotein (LDL) cholesterol levels
timeFrame: 3 months
measure: Change in glycated hemoglobin A1c (HbA1c) levels
timeFrame: 3 months
measure: Change in weight
timeFrame: 3 months
measure: Change in body mass index (BMI)
timeFrame: 3 months
measure: Change in body fat rate
timeFrame: 3 months
measure: Change in body lean rate
timeFrame: 3 months
measure: Change in C-reactive protein
timeFrame: 3 months
measure: Change in transaminases levels
timeFrame: 3 months
measure: Change in gamma glutamyl transferases (GGT)
timeFrame: 3 months
measure: Change in 8-iso-prostaglandin F2α levels
timeFrame: 3 months
measure: Change in creatinine levels
timeFrame: 3 months
measure: Change in creatinine clearance
timeFrame: 3 months
measure: Change in leptin levels
timeFrame: 3 months
measure: Change in adiponectin levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: CIC La conception
Study officials:
affiliation: Aix Marseille Université
name: Jean Francois Landrier, PhD
role: PRINCIPAL_INVESTIGATOR
References: