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A Study of Strawberries and Disease Risk (STRB)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01199848
First Posted: September 13, 2010
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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

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 ]

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 ]

Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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):

  1. Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
  2. Elevated fasting glucose (≥110 mg/dL and <126 mg/dL)
  3. Elevated fasting insulin (>75th percentile cutoff of 13.13 μU/mL)
  4. 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.
  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.
  6. Nonsmokers
  7. Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements
  8. 18 years of age and older
  9. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 9, 2010
First Posted: September 13, 2010
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institute for Food Safety and Health, United States:
nutrition
polyphenolic
strawberry
insulin resistance
metabolic syndrome

Additional relevant MeSH terms:
Inflammation
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders