Effects of a Standardized Freeze-dried Grape Powder on High Density Lipoprotein (HDL) Function in Metabolic Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Metabolic Syndrome X

In brief

The purpose of this study is to evaluate the effects of both chronic and acute grape ingestion in a population of men and women at higher risk for both type 2 diabetes and cardiovascular disease (metabolic syndrome).

Key facts

Study ID

NCT02542176

Run by

University of Connecticut

People needed

20

Starts

2015-10-01

Expected to finish

2018-03-01

Last updated by the study team

2018-03-23

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 30 to 70 years
• Having metabolic syndrome, meaning that subjects have at least 3 of the following characteristics:
• Waist circumference ≥ 102 cm for men and ≥ 88 cm for women
• Triglycerides ≥ 150 mg/dL
• HDL cholesterol < 40 mg/dL for men and < 50 mg/dL for women
• Blood pressure ≥ 130/85 mm Hg or taking an anti-hypertensive medication
• Fasting blood glucose ≥ 100 mg/dL

You may not qualify if…

• Do not fulfill the classification of metabolic syndrome
• History of diabetes mellitus, cardiovascular disease, stroke, renal problems, liver disease, endocrine disorder, inborn error of metabolism, eating disorder or cancer.
• Weight loss greater than 10% of body weight over preceding 4 weeks.
• Taking high-dose aspirin (≥150 mg/day) or anti-inflammatory prescriptions, or any triglyceride- or glucose-lowering prescriptions or supplements, such as insulin, sodium-glucose transport protein-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, Fibrates (e.g., fenofibrates, gemfibrozil), Niacin (e.g., high dose nicotinic acid, Niaspan) Sulphonylureas (e.g., Glucotrol, Amaryl), Thiazolidinediones (e.g., Avandia, ACTOS, Rezulin), Meglitinides (e.g., Prandin, Starlix), Biguanides (e.g., Metformin), Alpha-glucosidase inhibitors (e.g., Precose, Glyset), dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., Januvia, Onglyza), prescription fish oil (e.g., Lovaza, Vascepa), high dose chromium, high dose fish oil, or cinnamon supplements etc.
• Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, blood pressure higher than 160/100 mmHg, and waist circumference higher than 200 cm.
• Allergy to coconut, milk, wheat, grapes or an allergy/intolerance to the placebo ingredients.

Where it is running

• University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

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