This trial is active, not recruiting.

Conditions insulin resistance, nutritional disease, metabolic disease
Treatments strawberry, placebo1, placebo2
Sponsor Institute for Food Safety and Health, United States
Collaborator California Strawberry Commission
Start date October 2011
End date December 2017
Trial size 45 participants
Trial identifier NCT01457612, STR2 2011-076


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Placebo Comparator)
Placebo Beverage 1 without fiber
Placebo Beverage 1 without fiber
(Active Comparator)
Strawberry Beverage 20g/BID
20g twice per day (BID) in beverage
(Placebo Comparator)
Placebo Beverage 2 with Fiber
Placebo Beverage 2 with Fiber

Primary Outcomes

The chronic beneficial effect of polyphenolics from strawberry on impaired insulin signaling in insulin-resistant men and women
time frame: 10 weeks

Secondary Outcomes

The chronic beneficial effect of polyphenolics from strawberry on oxidative- and inflammatory-markers in insulin-resistant men and women
time frame: 10 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Must meet ONE or MORE of the criteria (1)-(5) associated with insulin resistance along with all other criteria listed (6)-(9): 1. Blood glucose concentration between140-199 mg/dL at 2hr from OGTT. 2. Elevated fasting glucose (110 mg/dL≤ Fasting blood glucose <126 mg/dL) 3. Elevated fasting insulin (>75th percentile cutoff of 13.13 μU/mL) 4. 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. 5. Waist circumference ≥ 110 cm because many epidemiology studies have been shown that waist circumferences may be related to insulin resistance. 6. Nonsmokers 7. Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements 8. 18 years of age and older 9. No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease Exclusion Criteria: - 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). - 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).

Additional Information

Official title Effect of 6 Weeks Strawberry Supplementation on Insulin Action and Associated Risk Factors in Insulin Resistant (IR) Subjects (STR2)
Principal investigator Indika Edirisinghe, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Institute for Food Safety and Health, United States.