Status:
COMPLETED
Maximizing the Anti-inflammatory Effects of Strawberry Bioavailability
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborating Sponsors:
California Strawberry Commission
Conditions:
Overweight
Healthy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Primary objective is to determine if the efficacy of strawberries delivering polyphenols to prevent metabolic inflammation will be influenced by timing of consumption relative to meal intake. Seconda...
Detailed Description
This study is a randomized, single blinded, 3 -arm, within-subjects, placebo-controlled, design utilizing a multiple sampling, and repeated measures paradigm to evaluate timing influence of consumptio...
Eligibility Criteria
Inclusion
- 18 years of age and older
- Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for Asian population
- Nonsmoker
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol
- Weight stable: not gained or lost weight +/- 5 kg in previous 3 months
Exclusion
- Men and women who smoke
- Past smokers: abstinence for minimum 2 years
- Men and women with known or suspected food intolerance, allergies or hypersensitivity
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations \> 125mg/dL
- Men and women who have uncontrolled blood pressure \>140 mmHg/90 mmHg
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are lactating
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
- Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Men and women who are vegans
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (\> 4 cups/d)
- Men and women who do excessive exercise regularly or athlete
- Unstable weight: gained or lost weight +/- 5 kg in previous 3 months
- Women who are taking hormonal contraceptive
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01856153
Start Date
July 1 2013
End Date
April 1 2014
Last Update
July 27 2021
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616