Obesity, Insulin Resistance Nutritional, Metabolic, Endocrine
Conditions
Interventions
Study design
A 12-week, randomized, double-blind, placebo-controlled, parallel-group trial conducted at a single center (Athens Euroclinic Hospital), approved by the hospital's Ethics Committee.
Inte
the code stayed masked to investigators and participants until database lock.
Controlling for lifestyle confounds
Participants were instructed to hold their baseline diet and activity constant, monito
Sponsors
Hellenic Institute of Nutrition
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults with obesity — BMI = 30 kg/m² 2. Otherwise healthy — free of any other diagnosed chronic disease 3. Willing and able to provide written informed consent prior to enrolment 4. Recruited via advertisements at Athens Euroclinic Hospital
Exclusion criteria
Exclusion criteria: 1. Pregnancy, breastfeeding, or plans to become pregnant during the study period 2. Diagnosed type 1 or type 2 diabetes mellitus currently treated with insulin or oral hypoglycaemic agents 3. Significant hepatic impairment or renal insufficiency 4. Prior bariatric surgery or planned bariatric surgery during the study period 5. Known hypersensitivity or allergy to berberine, mulberry, or chromium-containing compounds 6. Current use of anticoagulant or antiplatelet therapy 7. Use of any other weight-loss, glucose-lowering, or insulin-sensitizing nutritional supplement within 4 weeks prior to screening 8. Participation in another interventional clinical trial within 3 months prior to enrolment 9. Presence of any other diagnosed chronic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin sensitivity measured using the Matsuda Composite Insulin Sensitivity Index (ISI-Matsuda), derived from a 75g oral glucose tolerance test (glucose/insulin at 0, 60, 120 min). Calculated from a 75g oral glucose tolerance test (OGTT), using glucose and insulin concentrations sampled at 0 (fasting), 60, and 120 minutes, applying the modified three-time-point Matsuda formula. Analyzed on the log-transformed scale due to positive skew; results back-transformed to geometric mean ratios (GMR). at baseline (week 0) and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI Metric: kg/m² measured using Standard calculation from measured height and weight at baseline (week 0) and week 12;Visceral fat rating measured using Bioimpedance analysis (BIA) at baseline (week 0) and week 12;Total body fat mass measured using Bioimpedance analysis (BIA) at baseline (week 0) and week 12 | — |
Countries
Greece
Contacts
Public ContactKonstantinos Xenos
Outcome results
None listed