Effect of 6-week Strawberry Supplementation on Insulin Action (STR2)

NCT01457612 | Completed

• 1 other identifier: STR2 2011-076
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Nutritional Disease; Metabolic Disease

Keywords

Insulin Resistant; Dietary Supplements; Nutrition; Antioxidant; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks

Secondary Outcomes (1)

• The chronic beneficial effect of polyphenolics from strawberry on oxidative- and inflammatory-markers in insulin-resistant men and women

  10 Weeks

Study Arms (3)

Placebo1

PLACEBO COMPARATOR

Placebo Beverage 1 without fiber

Dietary Supplement: Placebo1

Strawberry

ACTIVE COMPARATOR

Strawberry Beverage 20g/BID

Dietary Supplement: Strawberry

Placebo2

PLACEBO COMPARATOR

Placebo Beverage 2 with Fiber

Dietary Supplement: Placebo2

Interventions

Strawberry DIETARY_SUPPLEMENT

20g twice per day (BID) in beverage

Strawberry

Placebo1 DIETARY_SUPPLEMENT

Placebo Beverage 1 without fiber

Placebo1

Placebo2 DIETARY_SUPPLEMENT

Placebo Beverage 2 with Fiber

Placebo2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Nonsmokers
• Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements
• years of age and older
• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease

You may not qualify if:

• 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).

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• California Strawberry Commission: collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (2)

• 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.

  PMID: 20595645 RESULT

• 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.

  PMID: 18816058 RESULT

MeSH Terms

Conditions

Insulin Resistance; Nutrition Disorders; Metabolic Diseases; Inflammation

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Indika Edirisinghe, Ph.D

  Institute for Food Safety and Health

  PRINCIPAL INVESTIGATOR

• Britt Burton-Freeman, Ph.D

  Institute for Food Safety and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)