Effect of 6-week Strawberry Supplementation on Insulin Action (STR2)

Completed · Not applicable · Has a placebo group

Conditions studied: Insulin Resistance, Nutritional Disease, Metabolic Disease

In brief

The primary study objective is to investigate the potential chronic beneficial effect of polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant individuals through their ability to modulate oxidative- and inflammatory-markers that lead to devastating disease, including, but not limited to, diabetes and cardiovascular disease.

Key facts

Study ID

NCT01457612

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

45

Starts

2011-10-01

Expected to finish

2013-03-01

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must meet ONE or MORE of the criteria (1)-(5) associated with insulin resistance along with all other criteria listed (6)-(9):
• Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
• Elevated fasting glucose (110 mg/dL≤ Fasting blood glucose <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 ≥ 110 cm 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

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.