The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia.

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Overweight; Obesity; Insulin Sensitivity

Treatments: Dietary Supplement: 500 mg of artichoke extract; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04616404

9321/14122018

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Treatment:

Dietary Supplement: 500 mg of artichoke extract

Control Group

Placebo Comparator group

Treatment:

Other: Placebo