Status:
COMPLETED
Effect of 6-week Strawberry Supplementation on Insulin Action (STR2)
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborating Sponsors:
California Strawberry Commission
Conditions:
Insulin Resistance
Nutritional Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 th...
Detailed Description
This study is a single-center, randomized and single blinded, placebo-controlled, 6-week, parallel design study with follow-up to evaluate strawberry-associated chronic improvements in insulin action ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01457612
Start Date
October 1 2011
End Date
March 1 2013
Last Update
February 8 2023
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616