N/A
N=10
Matrix on Fruit Constituent Bioavailability
Healthy Non-smoker
Bottom Line
View on ClinicalTrials.gov: NCT01908634 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: CMax in Polyphenol Anthocyanin Concentrations — 8.7; 22.1; 7.6; 11.3 nmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Milk-based Strawberry Beverage without meal (Dietary_supplement); Water-Based Strawberry Beverage without meal (Dietary_supplement); Milk-based strawberry Beverage with meal (Dietary_supplement); Water-Based strawberry Beverage with meal (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CMax in Polyphenol Anthocyanin Concentrations |
8.7; 22.1; 7.6; 11.3 | — |
Summary
Primary objective is to evaluate the influence of matrix on the bioavailability of key phytochemical constituents in fruits and their subsequent effect on chronic disease risk factors.
Eligibility Criteria
Inclusion Criteria
- Adult (18-78 years of age)
- Relatively healthy
- Non-smoker or past smoker with abstinence for at least 2 years
Exclusion Criteria
- Pregnant and/or breast feeding
- Smoker or past smoker with abstinence 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 lbs 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.
- Severe obesity as defined by >39.9 BMI or under weight for height (BMI <18.5)
Data sourced from ClinicalTrials.gov (NCT01908634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.