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

NCT ID: NCT04616404

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2019-08-05

Brief Summary

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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

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Conditions

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Insulin Sensitivity Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

Group Type ACTIVE_COMPARATOR

500 mg of artichoke extract

Intervention Type DIETARY_SUPPLEMENT

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

Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Tablets with no active ingredient

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Tablets with no active ingredient

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indena S.p.A

INDUSTRY

Sponsor Role collaborator

Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Pavia, PV, Italy

Site Status

Countries

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Italy

Other Identifiers

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9321/14122018

Identifier Type: -

Identifier Source: org_study_id