Impact of Poplar Propolis on Metabolic Disturbances of Insulin Resistance
Insulin Resistance
About this trial
This is an interventional prevention trial for Insulin Resistance focused on measuring Propolis
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.
Sites / Locations
- CIC La conception
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Propolis
Placebo
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 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.