A Study of Strawberries and Disease Risk

Completed · Not applicable · Has a placebo group

Conditions studied: Nutritional and Metabolic Diseases, Inflammation, Physiological Responses

In brief

The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation, known factors in your blood associated with disease risk, when eaten with a standard high fat/carbohydrate meal.

Key facts

Study ID

NCT01199848

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

29

Starts

2010-09-15

Expected to finish

2015-10-15

Last updated by the study team

2021-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible volunteers must meet ONE or MORE of the criteria (numbers 1-4) associated with insulin resistance along with all of the other criteria listed (numbers 5-9):
• Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
• Elevated fasting glucose (≥110 mg/dL and <126 mg/dL)
• Elevated fasting insulin (>75th percentile cutoff of 13.13 μU/mL)
• Insulin resistance defined by the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose [in millimoles per liter] × insulin [in microunits per milliliter]/22.5) values of at least 2.5.
• Waist circumference >102 cm (men) and > 88 cm (women) for screening visit invitation because many epidemiology studies have been shown that waist circumferences may be related to insulin resistance.
• Nonsmokers
• Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements
• 18 years of age and older
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease

You may not qualify if…

• Pregnant and/or lactating
• Allergy or intolerance to strawberries and dairy products.
• Current regular consumption of strawberries is > 2 servings per day.
• Fasting blood glucose ≥ 126 mg/dL. Subjects identified with elevated fasting blood glucose levels will be advised to contact their primary care physician for appropriate follow-up care.
• Taking over the counter antioxidant supplements or other supplements that may interfere with the study procedures or endpoints.
• Subjects with unusual dietary habits (e.g. pica).
• Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period).
• Excessive exercisers or trained athletes.
• Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, or other systemic diseases.
• Addicted to drugs and/or alcohol.
• Medically documented psychiatric or neurological disturbances.
• Smoker (past smoker may be allowed if cessation is > 2 years)

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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