White capsule containing 300 mg of apple extract (Malus Domestica) with glycosilated polyphenols (≥90%) including glycosilated phloritzin (15-30%), chlorogenic acid (10-25%) and quercetin (15-25%)

Indistinguishable capsules with similar dimension, colour, odour and taste

Endothelial Dysfunction

1 tablet per day at evening before sleeping

Apple polyphenols

Placebo

S. Orsola-Malpighi University Hospital

Effect of Apple Polyphenols on Vascular Oxidative Stress and Endothelium Function Study (APP trial_2016)

A Double-blind, Placebo-controlled, Randomized Clinical Trial on the Metabolic and Vascular Effects of a Dietary Supplementation With Apple Polyphenols in Overweight Subjects

Change in arterial diameter after ischemic stimulus

Claudio Borghi

Full Professor of Internal Medicine

University of Bologna

Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.
Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.

Overweight

Nutritional counseling

Equikilon-3 months

Equikilon-6 months

Fondazione IRCCS Policlinico San Matteo

Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause

Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Overweight Menopausal Women: a Pragmatic, Randomised Clinical Trial.

Difference in change in body weight between patients receiving the experimental product and those not assigned to its use

Difference in change in body weight between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product and those not assigned to its use

Difference in change in LDL cholesterol between patients receiving the experimental product and those not assigned to its use

Difference in change in triglycerides between patients receiving the experimental product and those not assigned to its use

Difference in change in homeostasis model assessment of insulin resistance between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in LDL cholesterol between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in triglycerides between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product and those not assigned to its use

Difference in change in anthropometric parameters describing fat distribution (waist circumference) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product and those not assigned to its use

Difference in change in body composition parameters (measured by bioelectrical impedance analysis) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product and those not assigned to its use

Difference in change in the severity of menopausal symptoms (using the Green Climacteric Scale) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product and those not assigned to its use

Difference in change in quality of life (measured by the SF-36 Health Survey) between patients receiving the experimental product for 6 months and those assigned to its use for 3 months

Riccardo Caccialanza

Principal Investigator

IRCCS Policlinico S. Matteo

Leonardo Medica Srl

1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.

1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Placebo: Placebo: 1200 mg per day for three months

1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Chlorogenic acid: Chologenic acid: 1200 mg per day for three months

Chlorogenic Acid

Total

Sex: Female, Male

Region of Enrollment

Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.

Body weight

Body mass index

Waist circumference was measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters.

Waist circumference

Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of diastolic blood pressure (DBP). The value was expressed on mmHg

Systolic blood pressure

Blood pressure was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of diastolic blood pressure (DBP). The value was expressed on mmHg.

Diastolic blood pressure

The blood sample for determining of fasting plasma glucose (FPG), was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Fasting plasma glucose

The blood sample for determining of 2-hour plasma glcuose (2-h PG), was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

2-hour plasma glucose

Glycated hemoglobin A1c

The blood sample for determining of triglycerides (TG), was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Triglycerides

The blood sample for determining of total cholesterol (TC) , was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Total cholesterol

The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.

High-density lipoprotein cholesterol (HDL-C)

The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.

Low-density lipoprotein cholesterol (LDL-C)

Very low-density lipoprotein (VLDL)

Glutamic oxaloacetic transaminase (GOT)

Glutamic pyruvic transaminase (GPT)

Creatinine

Uric Acid

Area under the curve of glucose was obtained using the trapezoidal integration.

Area under the curve of glucose (AUCG)

Area under the curve of insulin was obtained using the trapezoidal integration.

Area under the curve of insulin (AUCI)

Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).

Total insulin secretion

Calculated by Stumvoll index [1283 + 1.829 · insulin 30 min (pmol/L) -138.7 · glucose 30 min (mmol/L) + 3.772 · insulin 0 min (pmol/L)]

First phase of insulin secretion

Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]

Insulin sensitivity

Reflect the fasting glucose level after a 10- to 12-h overnight fast.

Fasting Plasma Glucose (FPG)

Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.

2 Hours Plasma Glucose (2-h PG)

Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.

Glycated Hemoglobin A1c (A1C)

After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).

Total Insulin Secretion

First Phase of Insulin Secretion

Insulin Sensitivity

Area Under the Curve of Glucose

Before and after intervention area under the curve of insulin

Area Under the Curve of Insulin

The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12

Body Weight

The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12

Body Mass Index

Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12

Waist Circumference (WC)

The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

Systolic Blood Pressure (SBP)

The Diastolic blood plessure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12

Diastolic Blood Plessure (DBP)

The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12

Triglycerides (TG)

The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12

Total Cholesterol (TC)

The HDL-C levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the HDL-C level at week 12

High-density Lipoprotein Cholesterol (HDL-C)

The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the LDL-C levels at week 12

Low-density Lipoprotein Cholesterol (LDL-C)

The VLDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12

Very-low Density Lipoprotein (VLDL)

Before and after intervention by spectrophotometry

Glutamic Pyruvic Transaminase (GPT)

Glutamic Oxaloacetic Transaminase (GOT)

The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12

The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinina levels at week 12.

Overall Study

Dra. Esperanza Martínez Abundis

Impaired Glucose Tolerance

Placebo: 1200 mg per day for three months

Chologenic acid: 1200 mg per day for three months

Chlorogenic acid

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

Effect of the Administration of Chlorogenic Acid on Glucemic Control, Insulin Secretion and Insulin Sensitivity in Patients With Impaired Glucose Tolerance

chlorogenic acid/adipositas

Effect of Apple Polyphenols on Vascular Oxidative Stress and Endothelium Function Study (APP trial_2016)

Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause

Effect of Chlorogenic Acid on Patients With Impaired Glucose Tolerance

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