OverweightNCT01856153
Maximizing the Anti-inflammatory Effects of Strawberry Bioavailability
A study testing Before meal, With Meal and After meal in people with Overweight and Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy
- What is being tested?
- Before meal, With Meal and After meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2013to 1 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Maximizing the Anti-inflammatory Effects of Strawberries: Understanding the Influence of Strawberry Anthocyanin Bioavailability in the Context of Meals
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.
Read the 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 consumption of strawberry-anthocyanin-associated acute effect on inflammatory markers.
A planned sample size of 18 will be recruited into the study. This study will require one initial screening visit, one pre-study visit, and 3 study visits. The study will take 4-5 weeks per subject to complete.
The initial screening visit will provide subject informed consent document and determine subject eligibility through height and weight measurements, vital signs, blood glucose test (finger prick), and completion of a survey related to general eating, health, and exercise habits.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at initial screening visit and collected at a pre-study visit to assess subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects will be instructed to avoid any berry products throughout the study and follow a strictly limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual diet pattern and physical activity. Prior each study visit, a dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.
Subject will arrive at the study visits fasted for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements) , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. Thereafter, blood sample collection will occur every 1 hour for the next 10 hours. During each study visit, subject will drink one of 3 drinks at fasting (right after fasting blood draw), 2nd drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw), based on randomization (1 strawberry-containing beverage and 2 identical placebo beverages). The sequences of receiving the beverage treatments at each visit will be randomized to one of three: strawberry-placebo-placebo, placebo-strawberry-placebo, or placebo-placebo-strawberry.
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety often resulting in increased intake.
- Conditions
- Overweight, Healthy
- Being tested
- Before meal, With Meal, After meal
- Keywords
- Bioavailability, Strawberry polyphenols, Time Influence
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Before mealDietary supplement
With MealDietary supplement
After mealDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Before meal | Other | Strawberry-Placebo-Placebo Receives: Dietary Supplement: Before meal |
| With Meal | Other | Placebo-Strawberry-Placebo Receives: Dietary Supplement: With Meal |
| After Meal | Other | Placebo-Placebo-Strawberry Receives: Dietary Supplement: After meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma polyphenol concentrations over 10 hours after strawberry beverage consumption at different time points.
The timing influence of strawberry consumption on bioavailability of strawberry polyphenols in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
Measured: 10 hours
Secondary outcomes (1)
Changes in inflammation markers over 10 hours after strawberry beverage consumption at different time points.
The timing influence of strawberry consumption on inflammation markers in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study start1 Jul 2013
- Primary completion1 Apr 2014
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Strawberry Commission
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856153
- Sponsor's protocol ID
- 2013-044
- Status last verified
- Jul 2021
- First submitted
- 3 May 2013
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Anti-inflammatory Effects of Strawberries: Understanding the Influence of Strawberry Anthocyanin Bioavailability in the Context of Meals
- ClinicalTrials.gov ID
- NCT01856153
- Acronym / sponsor ID
- 2013-044
- Conditions
- Overweight, Healthy
- Keywords
- Bioavailability, Strawberry polyphenols, Time Influence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- California Strawberry Commission
- Study start
- 1 Jul 2013
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
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 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.
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 consumption of strawberry-anthocyanin-associated acute effect on inflammatory markers.
A planned sample size of 18 will be recruited into the study. This study will require one initial screening visit, one pre-study visit, and 3 study visits. The study will take 4-5 weeks per subject to complete.
The initial screening visit will provide subject informed consent document and determine subject eligibility through height and weight measurements, vital signs, blood glucose test (finger prick), and completion of a survey related to general eating, health, and exercise habits.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at initial screening visit and collected at a pre-study visit to assess subjects' baseline dietary intake pattern. After reviewing baseline food records, subjects will be instructed to avoid any berry products throughout the study and follow a strictly limited polyphenolic diet for 3 days prior to the study visit, while maintaining their usual diet pattern and physical activity. Prior each study visit, a dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.
Subject will arrive at the study visits fasted for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After pre-study procedures (height, weight, waist circumferences, vital sign, and blood glucose measurements) , a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw at fasting. Thereafter, blood sample collection will occur every 1 hour for the next 10 hours. During each study visit, subject will drink one of 3 drinks at fasting (right after fasting blood draw), 2nd drink with the breakfast meal (2 hrs after fasting blood draw) and the 3rd drink at 2 hours after the breakfast meal (4 hrs after fasting blood draw), based on randomization (1 strawberry-containing beverage and 2 identical placebo beverages). The sequences of receiving the beverage treatments at each visit will be randomized to one of three: strawberry-placebo-placebo, placebo-strawberry-placebo, or placebo-placebo-strawberry.
Premenopausal female subjects will be studied during the follicular phase of their menstrual cycle because food intake tends to be more stable during the follicular phase (days 1-13) than during the luteal phase (days 14-28) when the rise in progesterone levels decrease satiety often resulting in increased intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before meal | Other | Dietary Supplement: Before mealStrawberry-Placebo-Placebo |
| With Meal | Other | Dietary Supplement: With MealPlacebo-Strawberry-Placebo |
| After Meal | Other | Dietary Supplement: After mealPlacebo-Placebo-Strawberry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Before meal | Dietary supplement | Before meal |
| With Meal | Dietary supplement | With Meal |
| After meal | Dietary supplement | After Meal |
Primary outcome
Changes in plasma polyphenol concentrations over 10 hours after strawberry beverage consumption at different time points.
Time frame: 10 hours
The timing influence of strawberry consumption on bioavailability of strawberry polyphenols in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
1 secondary outcome
Changes in inflammation markers over 10 hours after strawberry beverage consumption at different time points.
Time frame: 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- 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 Before meal, With Meal and After meal in people with Overweight and Healthy, 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 8 inclusion and 18 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 27 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in plasma polyphenol concentrations over 10 hours after strawberry beverage consumption at different time points. (time frame: 10 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 27 Jul 2021.