Insulin Sensitivity, Obesity, Overweight
Conditions
Keywords
impaired fasting glucose, Cynara cardunculus, Insulin Sensitivity, Obesity, Overweight
Brief summary
Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.
Interventions
DIETARY_SUPPLEMENT500 mg of artichoke extract
Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC)
OTHERPlacebo
Tablets with no active ingredient
Sponsors
Indena S.p.A
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* without history of cardiovascular disease (CVD), * not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins) * free of overt liver, renal and thyroid disease
Exclusion criteria
* smoking * drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes on glycemia | Day 0, after 1 month and after 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes on AST (UI/l), ALT (UI/l), GGT (U/l) | Day 0, after 1 month and after 2 months |
| Changes on insulin (mcU/ml) and HOMA index | Day 0, after 1 month and after 2 months |
| Changes on glycated hemoglobin (%) | Day 0, after 1 month and after 2 months |
| Changes on total cholesterol (mg/dl), HDL (mg/dl), total cholesterol/HLD, LDL (mg/dl), LDL/HDL, triglycerides (mg/dl), ApoA (mg/dl), ApoB (mg/dl), ApoB/ApoA, creatinine (mg/dl) | Day 0, after 1 month and after 2 months |
| Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg) | Day 0, after 1 month |
| Changes on waist circumference (cm) | Day 0, after 1 month |
| Changes on VAT (g), lean and fat mass (g) | Day 0, after 1 month |
| Changes on A1c-Derived Average Glucose (mmol/l) | Day 0, after 1 month and after 2 months |
Countries
Italy
Outcome results
None listed