Insulin ResistanceNCT05717881
Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance
A study testing Propolis in people with Insulin Resistance, run by Aix Marseille Université at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to 10 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) ≥ 30 kg/m2
- Insulin resistance defined as a HOMA-IR index > 1.85 for men and > 2.07 for women
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Poplar Propolis on Insulin Homeostasis and Pancreatic Cell Function in Insulin Resistant Subjects
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).
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- Propolis, Placebo
- Keywords
- Propolis
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (19)
Change in glucose homeostasis
Glycaemia at T0, T30, T60, T90 and T120 (mmol/L) mesured after after an oral glucose tolerance test (OGTT).
Measured: 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).
Measured: 3 months
Change in triglyceride levels
Enzymatic assay by spectrophotometry of triglycerides (mmol/L).
Measured: 3 months
Change in cholesterol levels
Enzymatic assay by spectrophotometry of cholesterol (mmol/L).
Measured: 3 months
Change in high density lipoprotein (HDL) cholesterol levels
Enzymatic assay by spectrophotometry of HDL cholesterol (mmol/L).
Measured: 3 months
Change in low density lipoprotein (LDL) cholesterol levels
Friedewald formula : LDL=cholesterol-HDL-(triglyceride/2,2) expressed in mmol/L.
Measured: 3 months
Change in glycated hemoglobin A1c (HbA1c) levels
HbA1c mass spectrometry assay (%).
Measured: 3 months
Change in weight
Weight measurement by scale (kg).
Measured: 3 months
Change in body mass index (BMI)
BMI calculated by weight (kg) / size (m) squared.
Measured: 3 months
Change in body fat rate
Fat mass rate estimated by impedancemetry (DEXA) (%).
Measured: 3 months
Change in body lean rate
Lean mass rate estimated by impedancemetry (DEXA) (%).
Measured: 3 months
Change in C-reactive protein
Enzymatic determination of CRP (mg/L).
Measured: 3 months
Change in transaminases levels
Enzymatic determination of alanine aminotransferase (ALAT) and aspartate aminotransférase (ASAT) (UI/L).
Measured: 3 months
Change in gamma glutamyl transferases (GGT)
Enzymatic determination of gamma glutamyl transferases (GGT) (UI/L).
Measured: 3 months
Change in 8-iso-prostaglandin F2α levels
Enzymatic determination of 8-iso-prostaglandin F2α (8-iso-PGF 2α) (pg/mL).
Measured: 3 months
Change in creatinine levels
Enzymatic determination of creatinine (mg/L).
Measured: 3 months
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).
Measured: 3 months
Change in leptin levels
Enzymatic determination of leptin (pg/mL).
Measured: 3 months
Change in adiponectin levels
Enzymatic determination of adiponectin (ng/mL).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start2 Jun 2020
- Primary completion30 Sep 2020
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aix Marseille Université
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Responsible party
- Principal investigator, Jean-Francois Landrier, Aix Marseille Université
- Investigators
- Jean Francois Landrier, PhD, Principal investigator, Aix Marseille Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717881
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Poplar Propolis on Insulin Homeostasis and Pancreatic Cell Function in Insulin Resistant Subjects
- ClinicalTrials.gov ID
- NCT05717881
- Acronym / sponsor ID
- 1
- Conditions
- Insulin Resistance
- Keywords
- Propolis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Aix Marseille UniversitéUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Dietary Supplement: PropolisPropolis 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 comparator | Dietary Supplement: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥ 30 kg/m2
- Insulin resistance defined as a HOMA-IR index > 1.85 for men and > 2.07 for women
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropolisPropolis 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 |
| PlaceboPlacebo 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 |
Primary outcome
Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M)
Time frame: 3 months
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
19 secondary outcomes
Change in glucose homeostasis
Time frame: 3 months
Change in insulin homeostasis
Time frame: 3 months
Change in triglyceride levels
Time frame: 3 months
Change in cholesterol levels
Time frame: 3 months
Change in high density lipoprotein (HDL) cholesterol levels
Time frame: 3 months
Change in low density lipoprotein (LDL) cholesterol levels
Time frame: 3 months
Change in glycated hemoglobin A1c (HbA1c) levels
Time frame: 3 months
Change in weight
Time frame: 3 months
Change in body mass index (BMI)
Time frame: 3 months
Change in body fat rate
Time frame: 3 months
Change in body lean rate
Time frame: 3 months
Change in C-reactive protein
Time frame: 3 months
Change in transaminases levels
Time frame: 3 months
Change in gamma glutamyl transferases (GGT)
Time frame: 3 months
Change in 8-iso-prostaglandin F2α levels
Time frame: 3 months
Change in creatinine levels
Time frame: 3 months
Change in creatinine clearance
Time frame: 3 months
Change in leptin levels
Time frame: 3 months
Change in adiponectin levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Francois Landrier, PhD principal investigator
Aix Marseille Université
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propolis in people with Insulin Resistance, run by Aix Marseille Université at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.