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

Study Overview
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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.

Official Title
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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

Conditions
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Insulin Sensitivity, Obesity, Overweight

Intervention / Treatment
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* Dietary Supplement: 500 mg of artichoke extract
* Other: Placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br> | Dietary Supplement: 500 mg of artichoke extract<br>* Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC)<br>|
| Placebo Comparator: Control Group<br> | Other: Placebo<br>* Tablets with no active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impaired fasting glucose, Cynara cardunculus, Insulin Sensitivity, Obesity, Overweight