Nutritional and Metabolic DiseasesSTRBNCT01199848
A Study of Strawberries and Disease Risk
A study testing 10G, 20G and 40G in people with Nutritional and Metabolic Diseases and Inflammation, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation, known factors in your blood associated with disease risk, when eaten with a standard high… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional and Metabolic Diseases, Inflammation, Physiological Responses
- What is being tested?
- 10G, 20G and 40G
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2010to 15 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible volunteers must meet ONE or MORE of the criteria (numbers 1-4) associated with insulin resistance along with all of the other criteria listed (numbers 5-9):
- Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
- Elevated fasting glucose (≥110 mg/dL and <126 mg/dL)
- Elevated fasting insulin (>75th percentile cutoff of 13.13 μU/mL)
- Insulin resistance defined by the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose [in millimoles per liter] × insulin [in microunits per milliliter]/22.5) values of at least 2.5.
- Waist circumference >102 cm (men) and > 88 cm (women) for screening visit invitation because many epidemiology studies have been shown that waist circumferences may be related to insulin resistance.
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- Nonsmokers
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements
- 18 years of age and older
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
Who cannot join
- Pregnant and/or lactating
- Allergy or intolerance to strawberries and dairy products.
- Current regular consumption of strawberries 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.
- Subjects with unusual dietary habits (e.g. pica).
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- Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg 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.
- Smoker (past smoker may be allowed if cessation is > 2 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Effect of Strawberry on Oxidative Stress- and Inflammatory-mediated Insulin Resistance (IR) in Humans: Combating a Major Risk Factor for Diabetes and Cardiovascular Disease Through Diet
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation, known factors in your blood associated with disease risk, when eaten with a standard high fat/carbohydrate meal.
Read the detailed description
The main study is a single-center, randomized, cross-over, 4-arm, dose-response, single- blinded, 6-hour postprandial study to evaluate the ability of strawberry powder to block meal-induced oxidative stress and inflammation and concomitantly improve postprandial insulin sensitivity and glucose handling.
A planned sample size of 45 will be recruited into the study. Thirty subjects for the main study and 15 subjects for the complement study. Subjects can participate in both studies and if subjects participate in both studies, there will be a time gap between the main study and the complement study due to the volume of blood permitted to collect within 56 days.
The complement study will be a 2-arm placebo controlled study following the exact same protocol as the main study, but using only one strawberry dose (Dose 3 as in the main study) and comparing the effects relative to a placebo that does not control for fiber.
The main study will take 5- 6 weeks per subject to complete and the complement study will take 1-2 weeks per subject to complete, depending on subject's schedule.
The procedures conducted at the screening visit include blood sampling by finger prick for a fasting blood sugar test and anthropometric measurements (height, weight, and waist circumference), vital sign measurements (blood pressure and heart rate) and completion of a series of questionnaires relating to volunteers' general health and eating habits. Volunteers may be asked to complete an oral glucose/sugar tolerance test (OGTT) at screening. Volunteers will be exempt from the OGTT procedure if other qualifying conditions are present. Briefly, subjects undergoing OGTT will be asked to drink a glucose drink (similar in taste to kool-aid) in the morning after a 10 hour fast. Blood glucose finger pricks will then be done at 1 hour and 2 hours for determination of glucose tolerance. If the OGTT is necessary, additional compensation will be provided.
If qualified, subjects will undergo a 7-day pre-study period during which they will be asked to record their usual diet intake for 3 days, including 2 weekdays and 1 weekend day, EITHER followed by randomization into 1 of 4 treatment beverage sequences for the main study: Placebo (Pbo), Strawberry Dose 1, Strawberry Dose 2 and Strawberry Dose 3, OR followed by randomization into 1 of 2 treatment (Placebo without fiber and Strawberry Dose 3) beverage sequences for the complement study.
We expect it to be very difficult to eliminate or severely restrict polyphenolic diet during the entire study period, therefore subjects will be asked to limit only berry product intake during the study period. However, subjects will be asked to limit all polyphenolic foods in their diet for 3 days prior to each study visit.
All subjects will consume the standard high fat/ carbohydrate meal (known to induce oxidative- and inflammatory- stress) accompanied by 1 of 4 test beverages (whole milk shake with or without strawberry powder) on four separate occasions for the main study OR 1 of 2 test beverages on two separate occasions for the complement study, so that each subject will serve as their own control.
Subjects 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 circumference, blood pressure, blood glucose finger prick) and while fasting, a registered nurse (RN) will place a catheter (flexible tubing) in subjects' arm for the purpose of drawing blood. This catheter will remain only throughout the study day. Approximately 1 tablespoon of blood will be taken at this time. The test meal and strawberry shake will be served and thereafter subjects will have blood draws (1 T each time) at designated time points for the next 6 hours. Each visit will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center on the IIT Campus for the duration of the visit. Blood samples will be collected at designated time points during the postprandial period for analysis of metabolic (insulin and glucose homeostasis), oxidative and inflammatory endpoint markers.
- Being tested
- Placebo, 10G, 20G, 40G, Placebonofiber
- Keywords
- nutrition, polyphenolic, strawberry, insulin resistance, metabolic syndrome
- Medical subject headings
- Nutritional and Metabolic Diseases, Inflammation, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Pbo
whole milk shake without strawberry powder served with the high fat/carbohydrate test meal
10GDietary supplement
Also called Dose 1
whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal
20GDietary supplement
Also called Dose 2
whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal
40GDietary supplement
Also called Dose 3
whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
PlacebonofiberDietary supplement
Placebo without Fiber
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Pbo Receives: Dietary Supplement: Placebo |
| 10G STRB powder | Experimental | Dose 1 Receives: Dietary Supplement: 10G |
| 20G STRB powder | Experimental | Dose 2 Receives: Dietary Supplement: 20G |
| 40G STRB powder | Experimental | Dose 3 Receives: Dietary Supplement: 40G |
| PlacebonoFiber | Placebo comparator | Placebo without fiber Receives: Dietary Supplement: Placebonofiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Insulin Levels for 6 Hours
Strawberry dose-response effect on Postprandial glycemic control in insulin resistant individuals.plasma insulin concentration is measured over 6 hours by Randox clinical analyzer, analyzed with SAS mixed model.
Measured: 6 hour postprandial study over 4 periods
Secondary outcomes (1)
Strawberry Dose-response Effect on Postprandial Oxidative Stress (Ox-LDL) in Insulin-resistant Men and Women in an Acute Postprandial Paradigm
Postprandial plasma Ox-LDL concentration was measured by ELISA method. Normalizing responses to subjects own baseline (Time 0) was analyzed by SAS mixed model.
Measured: 6 hours postprandial study over 4 periods(treatments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study start15 Sep 2010
- Primary completion15 Oct 2015
- Study completion15 Oct 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutritional and Metabolic DiseasesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Strawberry Commission
- Responsible party
- Sponsor
- Investigators
- Indika Edirisinghe, PhD, Principal investigator, Institute for Food Safety and HealthBritt Burton-Freeman, PhD, MS, Principal investigator, Institute for Food Safety and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199848
- Sponsor's protocol ID
- STRB 2010-033
- Acronym
- STRB
- Status last verified
- Jan 2021
- First submitted
- 9 Sep 2010
- Last updated
- 12 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Burton-Freeman B, Linares A, Hyson D, Kappagoda T. Strawberry modulates LDL oxidation and postprandial lipemia in response to high-fat meal in overweight hyperlipidemic men and women. J Am Coll Nutr. 2010 Feb;29(1):46-54. doi: 10.1080/07315724.2010.10719816.
PubMed 20595645Park E, Edirisinghe I, Wei H, Vijayakumar LP, Banaszewski K, Cappozzo JC, Burton-Freeman B. A dose-response evaluation of freeze-dried strawberries independent of fiber content on metabolic indices in abdominally obese individuals with insulin resistance in a randomized, single-blinded, diet-controlled crossover trial. Mol Nutr Food Res. 2016 May;60(5):1099-109. doi: 10.1002/mnfr.201500845. Epub 2016 Mar 29.
PubMed 26842771
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strawberry on Oxidative Stress- and Inflammatory-mediated Insulin Resistance (IR) in Humans: Combating a Major Risk Factor for Diabetes and Cardiovascular Disease Through Diet
- ClinicalTrials.gov ID
- NCT01199848
- Acronym / sponsor ID
- STRB / STRB 2010-033
- Keywords
- nutrition, polyphenolic, strawberry, insulin resistance, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- California Strawberry Commission
- Study start
- 15 Sep 2010 (actual)
- Primary completion
- 15 Oct 2015 (actual)
- Study completion
- 15 Oct 2015 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 12 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation, known factors in your blood associated with disease risk, when eaten with a standard high fat/carbohydrate meal.
Detailed description
The main study is a single-center, randomized, cross-over, 4-arm, dose-response, single- blinded, 6-hour postprandial study to evaluate the ability of strawberry powder to block meal-induced oxidative stress and inflammation and concomitantly improve postprandial insulin sensitivity and glucose handling.
A planned sample size of 45 will be recruited into the study. Thirty subjects for the main study and 15 subjects for the complement study. Subjects can participate in both studies and if subjects participate in both studies, there will be a time gap between the main study and the complement study due to the volume of blood permitted to collect within 56 days.
The complement study will be a 2-arm placebo controlled study following the exact same protocol as the main study, but using only one strawberry dose (Dose 3 as in the main study) and comparing the effects relative to a placebo that does not control for fiber.
The main study will take 5- 6 weeks per subject to complete and the complement study will take 1-2 weeks per subject to complete, depending on subject's schedule.
The procedures conducted at the screening visit include blood sampling by finger prick for a fasting blood sugar test and anthropometric measurements (height, weight, and waist circumference), vital sign measurements (blood pressure and heart rate) and completion of a series of questionnaires relating to volunteers' general health and eating habits. Volunteers may be asked to complete an oral glucose/sugar tolerance test (OGTT) at screening. Volunteers will be exempt from the OGTT procedure if other qualifying conditions are present. Briefly, subjects undergoing OGTT will be asked to drink a glucose drink (similar in taste to kool-aid) in the morning after a 10 hour fast. Blood glucose finger pricks will then be done at 1 hour and 2 hours for determination of glucose tolerance. If the OGTT is necessary, additional compensation will be provided.
If qualified, subjects will undergo a 7-day pre-study period during which they will be asked to record their usual diet intake for 3 days, including 2 weekdays and 1 weekend day, EITHER followed by randomization into 1 of 4 treatment beverage sequences for the main study: Placebo (Pbo), Strawberry Dose 1, Strawberry Dose 2 and Strawberry Dose 3, OR followed by randomization into 1 of 2 treatment (Placebo without fiber and Strawberry Dose 3) beverage sequences for the complement study.
We expect it to be very difficult to eliminate or severely restrict polyphenolic diet during the entire study period, therefore subjects will be asked to limit only berry product intake during the study period. However, subjects will be asked to limit all polyphenolic foods in their diet for 3 days prior to each study visit.
All subjects will consume the standard high fat/ carbohydrate meal (known to induce oxidative- and inflammatory- stress) accompanied by 1 of 4 test beverages (whole milk shake with or without strawberry powder) on four separate occasions for the main study OR 1 of 2 test beverages on two separate occasions for the complement study, so that each subject will serve as their own control.
Subjects 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 circumference, blood pressure, blood glucose finger prick) and while fasting, a registered nurse (RN) will place a catheter (flexible tubing) in subjects' arm for the purpose of drawing blood. This catheter will remain only throughout the study day. Approximately 1 tablespoon of blood will be taken at this time. The test meal and strawberry shake will be served and thereafter subjects will have blood draws (1 T each time) at designated time points for the next 6 hours. Each visit will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center on the IIT Campus for the duration of the visit. Blood samples will be collected at designated time points during the postprandial period for analysis of metabolic (insulin and glucose homeostasis), oxidative and inflammatory endpoint markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPbo |
| 10G STRB powder | Experimental | Dietary Supplement: 10GDose 1 |
| 20G STRB powder | Experimental | Dietary Supplement: 20GDose 2 |
| 40G STRB powder | Experimental | Dietary Supplement: 40GDose 3 |
| PlacebonoFiber | Placebo comparator | Dietary Supplement: PlacebonofiberPlacebo without fiber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Eligible volunteers must meet ONE or MORE of the criteria (numbers 1-4) associated with insulin resistance along with all of the other criteria listed (numbers 5-9):
- Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
- Elevated fasting glucose (≥110 mg/dL and <126 mg/dL)
- Elevated fasting insulin (>75th percentile cutoff of 13.13 μU/mL)
- Insulin resistance defined by the homeostasis model assessment method of insulin resistance (HOMA-IR) (glucose [in millimoles per liter] × insulin [in microunits per milliliter]/22.5) values of at least 2.5.
Key exclusion criteria (12 listed)
- Pregnant and/or lactating
- Allergy or intolerance to strawberries and dairy products.
- Current regular consumption of strawberries 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.
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 |
|---|---|---|
| PlaceboAlso: Pbowhole milk shake without strawberry powder served with the high fat/carbohydrate test meal | Dietary supplement | Placebo |
| 10GAlso: Dose 1whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal | Dietary supplement | 10G STRB powder |
| 20GAlso: Dose 2whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal | Dietary supplement | 20G STRB powder |
| 40GAlso: Dose 3whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal | Dietary supplement | 40G STRB powder |
| PlacebonofiberPlacebo without Fiber | Dietary supplement | PlacebonoFiber |
Primary outcome
Postprandial Insulin Levels for 6 Hours
Time frame: 6 hour postprandial study over 4 periods
Strawberry dose-response effect on Postprandial glycemic control in insulin resistant individuals.plasma insulin concentration is measured over 6 hours by Randox clinical analyzer, analyzed with SAS mixed model.
1 secondary outcome
Strawberry Dose-response Effect on Postprandial Oxidative Stress (Ox-LDL) in Insulin-resistant Men and Women in an Acute Postprandial Paradigm
Time frame: 6 hours postprandial study over 4 periods(treatments)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20595645Burton-Freeman B, Linares A, Hyson D, Kappagoda T. Strawberry modulates LDL oxidation and postprandial lipemia in response to high-fat meal in overweight hyperlipidemic men and women. J Am Coll Nutr. 2010 Feb;29(1):46-54. doi: 10.1080/07315724.2010.10719816.
- Derived from this study: PubMed 26842771Park E, Edirisinghe I, Wei H, Vijayakumar LP, Banaszewski K, Cappozzo JC, Burton-Freeman B. A dose-response evaluation of freeze-dried strawberries independent of fiber content on metabolic indices in abdominally obese individuals with insulin resistance in a randomized, single-blinded, diet-controlled crossover trial. Mol Nutr Food Res. 2016 May;60(5):1099-109. doi: 10.1002/mnfr.201500845. Epub 2016 Mar 29.
- 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.
Indika Edirisinghe, PhD principal investigator
Institute for Food Safety and Health
Britt Burton-Freeman, PhD, MS principal investigator
Institute for Food Safety and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10G, 20G and 40G in people with Nutritional and Metabolic Diseases and Inflammation, 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 10 inclusion and 12 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 12 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. 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?
Yes. Results are posted in the registry (first posted 12 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?
Postprandial Insulin Levels for 6 Hours (time frame: 6 hour postprandial study over 4 periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199848, which also lists 2 linked publications.
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 12 Feb 2021.