N/A
Completed N=29
A Study of Strawberries and Disease Risk
Nutritional and Metabolic Diseases · Inflammation · Physiological Responses
Source: ClinicalTrials.gov NCT01199848 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Postprandial Insulin Levels for 6 Hours — 63.9; 64.3; 60.2; 56.3 microIU/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postprandial Insulin Levels for 6 Hours |
63.9; 64.3; 60.2; 56.3 | — |
| SECONDARY Strawberry Dose-response Effect on Postprandial Oxidative Stress (Ox-LDL) in Insulin-resistant Men and Women in an Acute Postprandial Paradigm |
-0.1; -0.3; -3; -0.17 | — |
Eligibility Criteria
Inclusion Criteria
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 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01199848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.