Clinical trial NCT01457612: Effect of 6-week Strawberry Supplementation on Insulin Action (STR2)
Official title: Effect of 6 Weeks Strawberry Supplementation on Insulin Action and Associated Risk Factors in Insulin Resistant (IR) Subjects (STR2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Nutritional Disease
Metabolic Disease
Keywords: Insulin Resistant
Dietary Supplements
Nutrition
Antioxidant
Inflammation
Lead sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
Sponsor class: INDUSTRY
Collaborators: name: California Strawberry Commission
First posted: 2011-10-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: The chronic beneficial effect of polyphenolics from strawberry on impaired insulin signaling in insulin-resistant men and women
timeFrame: 10 weeks
Secondary outcomes:
measure: The chronic beneficial effect of polyphenolics from strawberry on oxidative- and inflammatory-markers in insulin-resistant men and women
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Nutrition Research Center
state: Illinois
Study officials:
affiliation: Institute for Food Safety and Health
name: Indika Edirisinghe, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Food Safety and Health
name: Britt Burton-Freeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Edirisinghe 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.