Clinical trial NCT04616404: The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia.
Official title: The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia: a Double-blind, Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Sensitivity
Obesity
Overweight
Keywords: impaired fasting glucose
Cynara cardunculus
Insulin Sensitivity
Obesity
Overweight
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
Collaborators: name: Indena S.p.A
First posted: 2020-11-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes on glycemia
timeFrame: Day 0, after 1 month and after 2 months
Secondary outcomes:
measure: 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)
timeFrame: Day 0, after 1 month and after 2 months
measure: Changes on AST (UI/l), ALT (UI/l), GGT (U/l)
timeFrame: Day 0, after 1 month and after 2 months
measure: Changes on insulin (mcU/ml) and HOMA index
timeFrame: Day 0, after 1 month and after 2 months
measure: Changes on glycated hemoglobin (%)
timeFrame: Day 0, after 1 month and after 2 months
measure: Changes on A1c-Derived Average Glucose (mmol/l)
timeFrame: Day 0, after 1 month and after 2 months
measure: Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)
timeFrame: Day 0, after 1 month
measure: Changes on waist circumference (cm)
timeFrame: Day 0, after 1 month
measure: Changes on VAT (g), lean and fat mass (g)
timeFrame: Day 0, after 1 month
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona ''Istituto Santa Margherita''
state: PV
Study officials:
References: