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

Primary Purpose

Insulin Sensitivity, Obesity, Overweight

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

500 mg of artichoke extract

Placebo

About this trial

This is an interventional treatment trial for Insulin Sensitivity focused on measuring impaired fasting glucose, Cynara cardunculus, Insulin Sensitivity, Obesity, Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

Azienda di Servizi alla Persona ''Istituto Santa Margherita''

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Changes on glycemia

Secondary Outcome Measures

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)

Changes on AST (UI/l), ALT (UI/l), GGT (U/l)

Changes on insulin (mcU/ml) and HOMA index

Changes on glycated hemoglobin (%)

Changes on A1c-Derived Average Glucose (mmol/l)

Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)

Changes on waist circumference (cm)

Changes on VAT (g), lean and fat mass (g)

Full Information

NCT ID

NCT04616404

First Posted

October 13, 2020

Last Updated

October 29, 2020

Sponsor

Azienda di Servizi alla Persona di Pavia

Collaborators

Indena S.p.A

1. Study Identification

Unique Protocol Identification Number

NCT04616404

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 26, 2018 (Actual)

Primary Completion Date

August 5, 2019 (Actual)

Study Completion Date

August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azienda di Servizi alla Persona di Pavia

Collaborators

Indena S.p.A

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Sensitivity, Obesity, Overweight

Keywords

impaired fasting glucose, Cynara cardunculus, Insulin Sensitivity, Obesity, Overweight

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Active Comparator

Arm Title

Control Group

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

500 mg of artichoke extract

Intervention Description

Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC)

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Tablets with no active ingredient

Primary Outcome Measure Information:

Title

Changes on glycemia

Time Frame