Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05717881
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: February 2023
• Source: Aix Marseille Université
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 10, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Dietary Supplement:
• Propolis
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
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.

Locations

Country	Name	City	State
France	CIC La conception	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Aix Marseille Université	Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	Change in glucose homeostasis	Glycaemia at T0, T30, T60, T90 and T120 (mmol/L) mesured after after an oral glucose tolerance test (OGTT).	3 months
Secondary	Change in insulin homeostasis	Insulinemia at T0, T30, T60, T90 and T120 (mUI/L) mesured after after an oral glucose tolerance test (OGTT).	3 months
Secondary	Change in triglyceride levels	Enzymatic assay by spectrophotometry of triglycerides (mmol/L).	3 months
Secondary	Change in cholesterol levels	Enzymatic assay by spectrophotometry of cholesterol (mmol/L).	3 months
Secondary	Change in high density lipoprotein (HDL) cholesterol levels	Enzymatic assay by spectrophotometry of HDL cholesterol (mmol/L).	3 months
Secondary	Change in low density lipoprotein (LDL) cholesterol levels	Friedewald formula : LDL=cholesterol-HDL-(triglyceride/2,2) expressed in mmol/L.	3 months
Secondary	Change in glycated hemoglobin A1c (HbA1c) levels	HbA1c mass spectrometry assay (%).	3 months
Secondary	Change in weight	Weight measurement by scale (kg).	3 months
Secondary	Change in body mass index (BMI)	BMI calculated by weight (kg) / size (m) squared.	3 months
Secondary	Change in body fat rate	Fat mass rate estimated by impedancemetry (DEXA) (%).	3 months
Secondary	Change in body lean rate	Lean mass rate estimated by impedancemetry (DEXA) (%).	3 months
Secondary	Change in C-reactive protein	Enzymatic determination of CRP (mg/L).	3 months
Secondary	Change in transaminases levels	Enzymatic determination of alanine aminotransferase (ALAT) and aspartate aminotransférase (ASAT) (UI/L).	3 months
Secondary	Change in gamma glutamyl transferases (GGT)	Enzymatic determination of gamma glutamyl transferases (GGT) (UI/L).	3 months
Secondary	Change in 8-iso-prostaglandin F2a levels	Enzymatic determination of 8-iso-prostaglandin F2a (8-iso-PGF 2a) (pg/mL).	3 months
Secondary	Change in creatinine levels	Enzymatic determination of creatinine (mg/L).	3 months
Secondary	Change in creatinine clearance	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).	3 months
Secondary	Change in leptin levels	Enzymatic determination of leptin (pg/mL).	3 months
Secondary	Change in adiponectin levels	Enzymatic determination of adiponectin (ng/mL).	3 months