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Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance

NCT05717881 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-02-08

No results posted yet for this study

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

Interventions

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER

  • Aix Marseille Université

    lead OTHER

Principal Investigators

  • Jean Francois Landrier, PhD · Aix Marseille Université

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2020-09-30
Completion
2021-09-10

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717881 on ClinicalTrials.gov