HealthySFMDNCT03596008
Acute Strawberry Intake on Endothelial Function
A study testing Active drink in people with Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary objectives of the study are (1) to evaluate the effects of acute dietary strawberry intake on measures of vascular function in healthy adults following a meal challenge, (2) to evaluate the effects of acute dietary strawberry intake on metabolic status, and (3) to assess intervention-associated metabolite… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2018to 12 Oct 2020
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 20 to 35 kg/m2
- Aged 18-45 years old
- Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trail
- Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests
- Able to provide informed consent and comply with study procedures
Who cannot join
- Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
- Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
- Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc),
- Unstable use of any medication/supplement
- Have a history of cancer, except for non-melanoma skin cancer within past 5 years
Show all 19Show fewer
- Addicted to drugs and/or alcohol (>4 drinks/day)
- Have been exposed to any non-registered drug product within last 30 days.
- Working overnight (e.g. 3rd shift of overnight workers)
- Excessive exercisers or trained athletes
- Have allergies/intolerances to strawberries
- Extreme dietary habits (ie. vegetarian/vegan)
- Excessive coffee/tea drinker (>4 cups/day)
- Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months)
- Donated blood within last 3 months
- Female who is pregnant, planning to be pregnant, breastfeeding
- Current regular consumption of berries which exceeds > 2 servings per day
- Any condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
- Fasting glucose concentration >125 mg/dL
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 Investigating the Effect of Acute Strawberry Intake on Endothelial Function Measured by Flow Mediated Dilation
The primary objectives of the study are (1) to evaluate the effects of acute dietary strawberry intake on measures of vascular function in healthy adults following a meal challenge, (2) to evaluate the effects of acute dietary strawberry intake on metabolic status, and (3) to assess intervention-associated metabolite and inflammatory signatures and their relationship to vascular function.
Read the detailed description
This study is a randomized, 2-arm, single-blinded, within subject cross-over trial focused on evaluating the effects of acute dietary strawberry intake on measures of vascular function, metabolic status, as well as metabolite and inflammatory signatures and their relationship to vascular function in healthy adults following a meal challenge.
A planned sample size of 15 will be enrolled into the study. This study will require one initial screening visit and 2 study visits. This study will take approximately 1 week per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 2 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws and ultrasound measurement throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed Health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. A baseline FMD procedure will be completed immediately after baseline blood sample collection. Afterwards, subjects will be randomized to receive the strawberry powder treatment or placebo based on randomized treatment sequences for 2 study visits immediately after fasting blood draw. The sequences of receiving the supplement at each visit will be randomly assigned to one of 2 following sequences: A-B or B-A Each study visit will involve with blood samples collection at time points 0 (fasting), 1, 2, 4, 6, and 24 hour (h) for assessment of change in metabolites and inflammatory signatures. FMD procedure will be conducted after completing the baseline blood draw and later at 2h, 4h, 6h, and 24h. A standard breakfast will be provided immediately after the 0h blood collection.
- Conditions
- Healthy
- Being tested
- Active drink, Placebo drink
- Keywords
- strawberry, monocytes, endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active drinkDietary supplement
Also called 25g strawberry drink
The freeze-dried strawberry powder (25 g) in active drink
Placebo drinkDietary supplement
Placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Active1 | Experimental | freeze-dried strawberry powder (25 g) in active drink Receives: Dietary Supplement: Active drink |
| Placebo | Placebo comparator | Placebo drink Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postprandial endothelial function using Flow Mediated Dilation (FMD) between 2 treatments
postprandial endothelial function using Flow Mediated Dilation (FMD)
Measured: Baseline to 6 hours
Secondary outcomes (2)
Change in plasma blood glucose concentration response between 2 treatments
blood glucose concentration response
Measured: Baseline to 24 hours
Change in plasma blood insulin concentration response between 2 treatments
blood insulin concentration response
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Jul 2018
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- Randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 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
- NCT03596008
- Sponsor's protocol ID
- IRB2018-065
- Acronym
- SFMD
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2018
- 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
- A Pilot Study Investigating the Effect of Acute Strawberry Intake on Endothelial Function Measured by Flow Mediated Dilation
- ClinicalTrials.gov ID
- NCT03596008
- Acronym / sponsor ID
- SFMD / IRB2018-065
- Conditions
- Healthy
- Keywords
- strawberry, monocytes, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
The primary objectives of the study are (1) to evaluate the effects of acute dietary strawberry intake on measures of vascular function in healthy adults following a meal challenge, (2) to evaluate the effects of acute dietary strawberry intake on metabolic status, and (3) to assess intervention-associated metabolite and inflammatory signatures and their relationship to vascular function.
Detailed description
This study is a randomized, 2-arm, single-blinded, within subject cross-over trial focused on evaluating the effects of acute dietary strawberry intake on measures of vascular function, metabolic status, as well as metabolite and inflammatory signatures and their relationship to vascular function in healthy adults following a meal challenge.
A planned sample size of 15 will be enrolled into the study. This study will require one initial screening visit and 2 study visits. This study will take approximately 1 week per subject to complete.
The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.
If willing and eligible to participate, subjects will be invited to participate in the study for 2 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration.
Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws and ultrasound measurement throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed Health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. A baseline FMD procedure will be completed immediately after baseline blood sample collection. Afterwards, subjects will be randomized to receive the strawberry powder treatment or placebo based on randomized treatment sequences for 2 study visits immediately after fasting blood draw. The sequences of receiving the supplement at each visit will be randomly assigned to one of 2 following sequences: A-B or B-A Each study visit will involve with blood samples collection at time points 0 (fasting), 1, 2, 4, 6, and 24 hour (h) for assessment of change in metabolites and inflammatory signatures. FMD procedure will be conducted after completing the baseline blood draw and later at 2h, 4h, 6h, and 24h. A standard breakfast will be provided immediately after the 0h blood collection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm
| Arm | Type | Receives |
|---|---|---|
| Active1 | Experimental | Dietary Supplement: Active drinkfreeze-dried strawberry powder (25 g) in active drink |
| Placebo | Placebo comparator | Dietary Supplement: Placebo drinkPlacebo drink |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) between 20 to 35 kg/m2
- Aged 18-45 years old
- Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trail
- Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (19 listed)
- Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years
- Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
- Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc),
- Unstable use of any medication/supplement
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 |
|---|---|---|
| Active drinkAlso: 25g strawberry drinkThe freeze-dried strawberry powder (25 g) in active drink | Dietary supplement | Active1 |
| Placebo drinkPlacebo drink | Dietary supplement | Placebo |
Primary outcome
Changes in postprandial endothelial function using Flow Mediated Dilation (FMD) between 2 treatments
Time frame: Baseline to 6 hours
postprandial endothelial function using Flow Mediated Dilation (FMD)
2 secondary outcomes
Change in plasma blood glucose concentration response between 2 treatments
Time frame: Baseline to 24 hours
Change in plasma blood insulin concentration response between 2 treatments
Time frame: Baseline to 24 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 Active drink in people with 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 5 inclusion and 19 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. Some participants in this study may receive a placebo. 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 postprandial endothelial function using Flow Mediated Dilation (FMD) between 2 treatments (time frame: Baseline to 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 27 Jul 2021.