Insulin ResistanceNCT01457612
Effect of 6-week Strawberry Supplementation on Insulin Action (STR2)
A study testing Strawberry in people with Insulin Resistance and Nutritional Disease, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary study objective is to investigate the potential chronic beneficial effect of polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant individuals through their ability to modulate oxidative- and inflammatory-markers that lead to devastating disease, including, but not… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Nutritional Disease, Metabolic Disease
- What is being tested?
- Strawberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2011to 1 Mar 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must meet ONE or MORE of the criteria (1)-(5) associated with insulin resistance along with all other criteria listed (6)-(9):
- Blood glucose concentration between140-199 mg/dL at 2hr from OGTT.
- Elevated fasting glucose (110 mg/dL≤ Fasting blood glucose <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 ≥ 110 cm 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 6 Weeks Strawberry Supplementation on Insulin Action and Associated Risk Factors in Insulin Resistant (IR) Subjects (STR2)
The primary study objective is to investigate the potential chronic beneficial effect of polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant individuals through their ability to modulate oxidative- and inflammatory-markers that lead to devastating disease, including, but not limited to, diabetes and cardiovascular disease.
Read the detailed description
This study is a single-center, randomized and single blinded, placebo-controlled, 6-week, parallel design study with follow-up to evaluate strawberry-associated chronic improvements in insulin action resulting in reduced whole body insulin resistance and improved glucose tolerance. This study will take approximately 11~12 weeks.
Subjects will follow an extremely limited polyphenolic diet throughout the duration of their participation in the study.
The limited diet will begin 7 days before the first study visit and end before the last study visit. Following the polyphenol-free 7-day run in period, at Week 0, subjects will be scheduled to return to the Center for sequence randomization, an Oral Glucose Tolerance Test (OGTT) as well as a Flow Mediated Dilation (FMD) procedure to measure endothelial function. Subjects will incorporate either one of tow Placebo Beverages (PBO1, n=15; PBO2, n=15) or Strawberry Beverage (STR, n=15, an optimal strawberry test dose of 40 g/d) into their diet daily for a period of 6 weeks. Subjects will consume randomly assigned beverage twice per day with their breakfast and dinner meals.
All subjects will be asked to come to the Center once a week where they will receive a week's supply of beverages. Additionally, fasting clinical and laboratory variables, anthropometrics, and vital sign measurements will be assessed at each bi-weekly visit at Week 3 and Week 5.
Participants will undergo the same procedures at the end of Week 6: fasting blood sample collection for analysis of insulin, glucose, oxidative and inflammatory markers, an OGTT to assess glucose handling, as well as a FMD procedure to assess endothelial function in response to 6 weeks of either the Placebo or Strawberry treatment.
Subjects will be required to visit the Center 4 weeks after the end of their intervention period (Week 10), at which time they will undergo their last anthropometrics and vital sign measurements, a 4 hour OGTT, and the FMD procedure.
- Conditions
- Insulin Resistance, Nutritional Disease, Metabolic Disease
- Being tested
- Strawberry, Placebo1, Placebo2
- Keywords
- Insulin Resistant, Dietary Supplements, Nutrition, Antioxidant, Inflammation
- Medical subject headings
- Insulin Resistance, Nutrition Disorders, Metabolic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrawberryDietary supplement
20g twice per day (BID) in beverage
Placebo1Dietary supplement
Placebo Beverage 1 without fiber
Placebo2Dietary supplement
Placebo Beverage 2 with Fiber
| Study group | Role | What they receive |
|---|---|---|
| Placebo1 | Placebo comparator | Placebo Beverage 1 without fiber Receives: Dietary Supplement: Placebo1 |
| Strawberry | Active comparator | Strawberry Beverage 20g/BID Receives: Dietary Supplement: Strawberry |
| Placebo2 | Placebo comparator | Placebo Beverage 2 with Fiber Receives: Dietary Supplement: Placebo2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The chronic beneficial effect of polyphenolics from strawberry on impaired insulin signaling in insulin-resistant men and women
Subjects will be randomized to receive either one of beverages, Pbo1, Pbo2 or Str Beverage and consume randomly assigned beverage twice per day with their breakfast and dinner meals for 6 weeks. On visits at Wk0, Wk6, and Wk10, blood will be collected at 0h, and 1h, 2h, 3h and 4h time points following the 75 g glucose load (oral glucose tolerance test) and Flow Mediated Dilation (FMD) procedure will be performed as well.
Measured: 10 weeks
Secondary outcomes (1)
The chronic beneficial effect of polyphenolics from strawberry on oxidative- and inflammatory-markers in insulin-resistant men and women
Samples of venous blood will be collected for measurement of oxidative and inflammatory markers (hs-CRP levels, LDL oxidation, Interleukin (IL)-6 and other inflammatory molecules, Total antioxidant levels of the blood)
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study start1 Oct 2011
- Primary completion1 Dec 2012
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Strawberry Commission
- Responsible party
- Sponsor
- Investigators
- Indika Edirisinghe, Ph.D, Principal investigator, Institute for Food Safety and HealthBritt Burton-Freeman, Ph.D, Principal investigator, Institute for Food Safety and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457612
- Sponsor's protocol ID
- STR2 2011-076
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2011
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- 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 20595645Edirisinghe I, Burton-Freeman B, Varelis P, Kappagoda T. Strawberry extract caused endothelium-dependent relaxation through the activation of PI3 kinase/Akt. J Agric Food Chem. 2008 Oct 22;56(20):9383-90. doi: 10.1021/jf801864t. Epub 2008 Sep 25.
PubMed 18816058
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 6 Weeks Strawberry Supplementation on Insulin Action and Associated Risk Factors in Insulin Resistant (IR) Subjects (STR2)
- ClinicalTrials.gov ID
- NCT01457612
- Acronym / sponsor ID
- STR2 2011-076
- Conditions
- Insulin Resistance, Nutritional Disease, Metabolic Disease
- Keywords
- Insulin Resistant, Dietary Supplements, Nutrition, Antioxidant, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- California Strawberry Commission
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 24 Oct 2011 (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.
The primary study objective is to investigate the potential chronic beneficial effect of polyphenolics derived from strawberry on impaired insulin signaling in insulin resistant individuals through their ability to modulate oxidative- and inflammatory-markers that lead to devastating disease, including, but not limited to, diabetes and cardiovascular disease.
Detailed description
This study is a single-center, randomized and single blinded, placebo-controlled, 6-week, parallel design study with follow-up to evaluate strawberry-associated chronic improvements in insulin action resulting in reduced whole body insulin resistance and improved glucose tolerance. This study will take approximately 11~12 weeks.
Subjects will follow an extremely limited polyphenolic diet throughout the duration of their participation in the study.
The limited diet will begin 7 days before the first study visit and end before the last study visit. Following the polyphenol-free 7-day run in period, at Week 0, subjects will be scheduled to return to the Center for sequence randomization, an Oral Glucose Tolerance Test (OGTT) as well as a Flow Mediated Dilation (FMD) procedure to measure endothelial function. Subjects will incorporate either one of tow Placebo Beverages (PBO1, n=15; PBO2, n=15) or Strawberry Beverage (STR, n=15, an optimal strawberry test dose of 40 g/d) into their diet daily for a period of 6 weeks. Subjects will consume randomly assigned beverage twice per day with their breakfast and dinner meals.
All subjects will be asked to come to the Center once a week where they will receive a week's supply of beverages. Additionally, fasting clinical and laboratory variables, anthropometrics, and vital sign measurements will be assessed at each bi-weekly visit at Week 3 and Week 5.
Participants will undergo the same procedures at the end of Week 6: fasting blood sample collection for analysis of insulin, glucose, oxidative and inflammatory markers, an OGTT to assess glucose handling, as well as a FMD procedure to assess endothelial function in response to 6 weeks of either the Placebo or Strawberry treatment.
Subjects will be required to visit the Center 4 weeks after the end of their intervention period (Week 10), at which time they will undergo their last anthropometrics and vital sign measurements, a 4 hour OGTT, and the FMD procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo1 | Placebo comparator | Dietary Supplement: Placebo1Placebo Beverage 1 without fiber |
| Strawberry | Active comparator | Dietary Supplement: StrawberryStrawberry Beverage 20g/BID |
| Placebo2 | Placebo comparator | Dietary Supplement: Placebo2Placebo Beverage 2 with Fiber |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must meet ONE or MORE of the criteria (1)-(5) associated with insulin resistance along with all other criteria listed (6)-(9):
Key exclusion criteria (12 listed)
- Pregnant and/or lactating.
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 |
|---|---|---|
| Strawberry20g twice per day (BID) in beverage | Dietary supplement | Strawberry |
| Placebo1Placebo Beverage 1 without fiber | Dietary supplement | Placebo1 |
| Placebo2Placebo Beverage 2 with Fiber | Dietary supplement | Placebo2 |
Primary outcome
The chronic beneficial effect of polyphenolics from strawberry on impaired insulin signaling in insulin-resistant men and women
Time frame: 10 weeks
Subjects will be randomized to receive either one of beverages, Pbo1, Pbo2 or Str Beverage and consume randomly assigned beverage twice per day with their breakfast and dinner meals for 6 weeks. On visits at Wk0, Wk6, and Wk10, blood will be collected at 0h, and 1h, 2h, 3h and 4h time points following the 75 g glucose load (oral glucose tolerance test) and Flow Mediated Dilation (FMD) procedure will be performed as well.
1 secondary outcome
The chronic beneficial effect of polyphenolics from strawberry on oxidative- and inflammatory-markers in insulin-resistant men and women
Time frame: 10 Weeks
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 8 Feb 2023.
- Results publication: 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.
- Results publication: PubMed 18816058Edirisinghe I, Burton-Freeman B, Varelis P, Kappagoda T. Strawberry extract caused endothelium-dependent relaxation through the activation of PI3 kinase/Akt. J Agric Food Chem. 2008 Oct 22;56(20):9383-90. doi: 10.1021/jf801864t. Epub 2008 Sep 25.
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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, Ph.D principal investigator
Institute for Food Safety and Health
Britt Burton-Freeman, Ph.D 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 Strawberry in people with Insulin Resistance and Nutritional Disease, 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 8 Feb 2023. 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?
The chronic beneficial effect of polyphenolics from strawberry on impaired insulin signaling in insulin-resistant men and women (time frame: 10 weeks). 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 NCT01457612, 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 8 Feb 2023.