Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

NCT05717881 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Insulin Resistance

Keywords

Propolis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change in glucose homeostasis

  3 months

• Change in insulin homeostasis

  3 months

• Change in triglyceride levels

  3 months

• Change in cholesterol levels

  3 months

• Change in high density lipoprotein (HDL) cholesterol levels

  3 months

Study Arms (2)

Propolis

EXPERIMENTAL

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.

Dietary Supplement: Propolis

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

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.

Propolis

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aix Marseille Université: lead
• Assistance Publique Hopitaux De Marseille: collaborator

Study Sites (1)

CIC La conception

Marseille, France

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Propolis

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Jean Francois Landrier, PhD

  Aix Marseille Université

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: June 2, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 10, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)