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

NCT04616404 | Completed

• 1 other identifier: 9321/14122018
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Sensitivity; Obesity; Overweight

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes on glycemia

  Day 0, after 1 month and after 2 months

Secondary Outcomes (8)

• 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

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Dietary Supplement: 500 mg of artichoke extract

Control Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

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)

Intervention Group

Placebo OTHER

Tablets with no active ingredient

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• smoking
• drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead
• Indena S.p.A: collaborator

Study Sites (1)

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

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Overweight

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: November 5, 2020
• Study Start: July 26, 2018
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-10

Locations

IT (1)