Maximizing the Anti-inflammatory Effects of Strawberry Bioavailability

Completed · Not applicable

Conditions studied: Overweight, Healthy

In brief

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. Secondary objective is to characterize the relative bioavailability and absorption profile of strawberry polyphenols consumed with meal or at alternatives times around a meal (2 hours before the meal ad 2 hours after the meal). Third objective is to determine the bioavailability/absorption profile of strawberry polyphenols and its relationship with the anti-inflammatory mechanism of action of strawberry constituents.

Key facts

Study ID

NCT01856153

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

22

Starts

2013-07-01

Expected to finish

2014-04-01

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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