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

Not Applicable

Completed

• Conditions: Overweight; Insulin Sensitivity; Obesity
• Interventions: Other: Placebo; Dietary Supplement: 500 mg of artichoke extract

• Registration Number: NCT04616404
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-26
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Status Verified: 2020-10
• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	-
Intervention Group	500 mg of artichoke extract	-

Primary Outcome Measures

Name	Time	Method
Changes on glycemia	Day 0, after 1 month and after 2 months

Secondary Outcome Measures

Name	Time	Method
Changes on VAT (g), lean and fat mass (g)	Day 0, after 1 month
Changes on glycated hemoglobin (%)	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 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 AST (UI/l), ALT (UI/l), GGT (U/l)	Day 0, after 1 month and after 2 months
Changes on A1c-Derived Average Glucose (mmol/l)	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

Trial Locations

Locations (1)

Azienda di Servizi alla Persona ''Istituto Santa Margherita''; 🇮🇹 Pavia, PV, Italy