A Study of Strawberries and Disease Risk (STRB)

This study is ongoing, but not recruiting participants.
Sponsor:
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: November 21, 2013
Last verified: November 2013
  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 2014
Estimated Primary Completion Date: October 2014 (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):

  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
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, see Learn About Clinical Studies.

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: November 21, 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:
Insulin Resistance
Inflammation
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014