Healthy Non-smokerFRTNCT01908634
Matrix on Fruit Constituent Bioavailability
A study testing Milk-based Strawberry Beverage without meal, Water-Based Strawberry Beverage without meal and Milk-based strawberry Beverage with meal in people with Healthy Non-smoker, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Non-smoker
- What is being tested?
- Milk-based Strawberry Beverage without meal, Water-Based Strawberry Beverage without meal and Milk-based strawberry Beverage with meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 30 Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18-78 years of age)
- Relatively healthy
- Non-smoker or past smoker with abstinence for at least 2 years
Who cannot join
- Pregnant and/or breast feeding
- Smoker or past smoker with abstinence <2 years
- Allergy or intolerance to study foods
- Current regular consumption of berries 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.
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.
Read the detailed description
This study is a single-center, randomized, cross-over, 4-arm, single- blinded, 6-hour postprandial study to evaluate the effects of strawberry or comparator fruit provided in a formulated beverage with milk (as the base) or water or fresh/pureed.
A planned sample size of 10 men and women will be recruited into the study. Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic screening mechanisms, including questionnaires, fasting glucose concentration, and anthropometric measurements. Eligible subjects will be invited to participate in the study. Subjects will begin by completing a 3-day pre-study assessment of their usual dietary intake using 3-day food diary. After reviewing baseline food records, subjects will be instructed to avoid polyphenolic-containing foods for 2 days prior to the study visit, while maintaining their usual diet pattern and physical activity.
Subjects will participate in 6 h postprandial study days. Subjects will be randomized on the first day of starting the first post prandial visit day.
For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures published by our lab previously. This includes: pre-study evaluation for compliance (fasting, dinner consumption, limited polyphenol intake) and readiness for study visit, catheter placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate meal accompanied by 1 of the treatment beverages, subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time points for 6 hours.
Each postprandial study visit day will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois Institute of Technology main campus for the duration of the visit. The visit procedures are repeated four times ~ 1 week apart to accommodate subject testing with all four beverages; all procedures are identical on each postprandial study test visit with the exception that only an assigned test beverage per each visit will be consumed with the breakfast.
- Conditions
- Healthy Non-smoker
- Being tested
- Milk-based Strawberry Beverage without meal, Water-Based Strawberry Beverage without meal, Milk-based strawberry Beverage with meal, Water-Based strawberry Beverage with meal
- Keywords
- Bioavailability, Strawberry polyphenols, Fruit Beverage Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk-based Strawberry Beverage without mealDietary supplement
Water-Based Strawberry Beverage without mealDietary supplement
Milk-based strawberry Beverage with mealDietary supplement
Water-Based strawberry Beverage with mealDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Milk-based Strawberry Beverage no meal | Active comparator | Milk-based Strawberry beverage without meal Receives: Dietary Supplement: Milk-based Strawberry Beverage without meal |
| Water-based Strawberry Beverage no meal | Experimental | Water-based Strawberry beverage without meal Receives: Dietary Supplement: Water-Based Strawberry Beverage without meal |
| Milk-based strawberry Beverage with meal | Active comparator | Milk-based Strawberry beverage with meal Receives: Dietary Supplement: Milk-based strawberry Beverage with meal |
| Water-based strawberry Beverage with meal | Experimental | Water-based Strawberry beverage with meal Receives: Dietary Supplement: Water-Based strawberry Beverage with meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMax in Polyphenol Anthocyanin Concentrations
Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study start1 Jul 2013
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Non-smokerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908634
- Sponsor's protocol ID
- 2013-076
- Acronym
- FRT
- Status last verified
- Jan 2021
- First submitted
- 23 Jul 2013
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.
- ClinicalTrials.gov ID
- NCT01908634
- Acronym / sponsor ID
- FRT / 2013-076
- Conditions
- Healthy Non-smoker
- Keywords
- Bioavailability, Strawberry polyphenols, Fruit Beverage Matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 11 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-center, randomized, cross-over, 4-arm, single- blinded, 6-hour postprandial study to evaluate the effects of strawberry or comparator fruit provided in a formulated beverage with milk (as the base) or water or fresh/pureed.
A planned sample size of 10 men and women will be recruited into the study. Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic screening mechanisms, including questionnaires, fasting glucose concentration, and anthropometric measurements. Eligible subjects will be invited to participate in the study. Subjects will begin by completing a 3-day pre-study assessment of their usual dietary intake using 3-day food diary. After reviewing baseline food records, subjects will be instructed to avoid polyphenolic-containing foods for 2 days prior to the study visit, while maintaining their usual diet pattern and physical activity.
Subjects will participate in 6 h postprandial study days. Subjects will be randomized on the first day of starting the first post prandial visit day.
For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures published by our lab previously. This includes: pre-study evaluation for compliance (fasting, dinner consumption, limited polyphenol intake) and readiness for study visit, catheter placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate meal accompanied by 1 of the treatment beverages, subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time points for 6 hours.
Each postprandial study visit day will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois Institute of Technology main campus for the duration of the visit. The visit procedures are repeated four times ~ 1 week apart to accommodate subject testing with all four beverages; all procedures are identical on each postprandial study test visit with the exception that only an assigned test beverage per each visit will be consumed with the breakfast.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk-based Strawberry Beverage no meal | Active comparator | Dietary Supplement: Milk-based Strawberry Beverage without mealMilk-based Strawberry beverage without meal |
| Water-based Strawberry Beverage no meal | Experimental | Dietary Supplement: Water-Based Strawberry Beverage without mealWater-based Strawberry beverage without meal |
| Milk-based strawberry Beverage with meal | Active comparator | Dietary Supplement: Milk-based strawberry Beverage with mealMilk-based Strawberry beverage with meal |
| Water-based strawberry Beverage with meal | Experimental | Dietary Supplement: Water-Based strawberry Beverage with mealWater-based Strawberry beverage with meal |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18-78 years of age)
- Relatively healthy
- Non-smoker or past smoker with abstinence for at least 2 years
Key exclusion criteria (13 listed)
- Pregnant and/or breast feeding
- Smoker or past smoker with abstinence <2 years
- Allergy or intolerance to study foods
- Current regular consumption of berries 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk-based Strawberry Beverage without meal | Dietary supplement | Milk-based Strawberry Beverage no meal |
| Water-Based Strawberry Beverage without meal | Dietary supplement | Water-based Strawberry Beverage no meal |
| Milk-based strawberry Beverage with meal | Dietary supplement | Milk-based strawberry Beverage with meal |
| Water-Based strawberry Beverage with meal | Dietary supplement | Water-based strawberry Beverage with meal |
Primary outcome
CMax in Polyphenol Anthocyanin Concentrations
Time frame: 6 hours
Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk-based Strawberry Beverage without meal, Water-Based Strawberry Beverage without meal and Milk-based strawberry Beverage with meal in people with Healthy Non-smoker, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMax in Polyphenol Anthocyanin Concentrations (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.