A Study of Strawberries and Disease Risk (STRB)
This study is ongoing, but not recruiting participants.
Sponsor:
Institute for Food Safety and Health, United States
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT01199848
First received: September 9, 2010
Last updated: May 19, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Nutritional and Metabolic Diseases Inflammation Physiological Responses |
Dietary Supplement: Placebo Dietary Supplement: 10G Dietary Supplement: 20G Dietary Supplement: 40G Dietary Supplement: Placebonofiber |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Effect of Strawberry on Oxidative Stress- and Inflammatory-mediated Insulin Resistance (IR) in Humans: Combating a Major Risk Factor for Diabetes and Cardiovascular Disease Through Diet |
Resource links provided by NLM:
Further study details as provided by Institute for Food Safety and Health, United States:
Primary Outcome Measures:
- The ability of strawberries to modulate postprandial oxidative stress and inflammation in insulin-resistant men and women in an acute postprandial paradigm [ Time Frame: 6 hour postprandial study over 4-6 week period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The ability of strawberries plus fiber to understand insulin signaling in insulin resistant individuals. [ Time Frame: 6 hours postprandial study over 2-week period ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Pbo
|
Dietary Supplement: Placebo
whole milk shake without strawberry powder served with the high fat/carbohydrate test meal
Other Name: Pbo
|
|
Experimental: 10G STRB powder
Dose 1
|
Dietary Supplement: 10G
whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal
Other Name: Dose 1
|
|
Experimental: 20G STRB powder
Dose 2
|
Dietary Supplement: 20G
whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal
Other Name: Dose 2
|
|
Experimental: 40G STRB powder
Dose 3
|
Dietary Supplement: 40G
whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
Other Name: Dose 3
|
|
Placebo Comparator: PlacebonoFiber
Placebo without fiber
|
Dietary Supplement: Placebonofiber
Placebo without Fiber
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 <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
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199848
Locations
| United States, Illinois | |
| Clinical Nutrition Research Center | |
| Chicago, Illinois, United States, 60616 | |
Sponsors and Collaborators
Institute for Food Safety and Health, United States
California Strawberry Commission
Investigators
| Principal Investigator: | Indika Edirisinghe, PhD | Institute for Food Safety and Health |
| Principal Investigator: | Britt Burton-Freeman, PhD, MS | Institute for Food Safety and Health |
More Information
Publications:
| Responsible Party: | Institute for Food Safety and Health, United States |
| ClinicalTrials.gov Identifier: | NCT01199848 History of Changes |
| Other Study ID Numbers: | STRB 2010-033 |
| Study First Received: | September 9, 2010 |
| Last Updated: | May 19, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Institute for Food Safety and Health, United States:
|
nutrition polyphenolic strawberry insulin resistance metabolic syndrome |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Inflammation Insulin Resistance Metabolic Diseases |
Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders |
ClinicalTrials.gov processed this record on June 17, 2013