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Completed

NCT Number: NCT04616404

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

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.

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Key information

Conditions

Insulin Sensitivity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, PV, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

500 mg of artichoke extract

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)

Placebo

Other

Tablets with no active ingredient

Primary outcomes

  1. Changes on glycemia

    Time frame: Day 0, after 1 month and after 2 months

Secondary outcomes

  1. 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)

    Time frame: Day 0, after 1 month and after 2 months

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

    Time frame: Day 0, after 1 month and after 2 months

  3. Changes on insulin (mcU/ml) and HOMA index

    Time frame: Day 0, after 1 month and after 2 months

  4. Changes on glycated hemoglobin (%)

    Time frame: Day 0, after 1 month and after 2 months

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

    Time frame: Day 0, after 1 month and after 2 months

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

    Time frame: Day 0, after 1 month

  7. Changes on waist circumference (cm)

    Time frame: Day 0, after 1 month

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

    Time frame: Day 0, after 1 month

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Collaborators

  • Indena S.p.A

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 5, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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