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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Insulin Sensitivity
• Intervention / Treatment: Dietary supplement: 500 mg of artichoke extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Azienda di Servizi alla Persona ''Istituto Santa Margherita''

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Other: Placebo; Tablets with no active ingredient
Active Comparator: Intervention Group	Dietary supplement: 500 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes on glycemia	Day 0, after 1 month and after 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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
Changes on VAT (g), lean and fat mass (g)	Day 0, after 1 month

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Collaborators: Indena S.p.A

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): August 5, 2019

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Insulin Sensitivity; impaired fasting glucose; Cynara cardunculus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Body Weight; Hyperinsulinism; Hypersensitivity; Insulin Resistance; Overweight
• Other Study ID Numbers: 9321/14122018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No