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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616404
• Other study ID #: 9321/14122018
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: August 5, 2019

Study information

• Verified date: October 2020
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity
• Obesity
• Overweight

Intervention

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)

Other:
• Placebo
Tablets with no active ingredient

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona ''Istituto Santa Margherita''	Pavia	PV

Sponsors (2)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia	Indena S.p.A

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on glycemia		Day 0, after 1 month and after 2 months
Secondary	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
Secondary	Changes on AST (UI/l), ALT (UI/l), GGT (U/l)		Day 0, after 1 month and after 2 months
Secondary	Changes on insulin (mcU/ml) and HOMA index		Day 0, after 1 month and after 2 months
Secondary	Changes on glycated hemoglobin (%)		Day 0, after 1 month and after 2 months
Secondary	Changes on A1c-Derived Average Glucose (mmol/l)		Day 0, after 1 month and after 2 months
Secondary	Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)		Day 0, after 1 month
Secondary	Changes on waist circumference (cm)		Day 0, after 1 month
Secondary	Changes on VAT (g), lean and fat mass (g)		Day 0, after 1 month