A Study of Strawberries and Disease Risk

NCT01199848 | Completed Results

• 1 other identifier: STRB 2010-033
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 fat/carbohydrate meal.

Conditions

Nutritional and Metabolic Diseases; Inflammation; Physiological Responses

Keywords

nutrition; polyphenolic; strawberry; insulin resistance; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  6 hours postprandial study over 4 periods(treatments)

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Pbo

Dietary Supplement: Placebo

10G STRB powder

EXPERIMENTAL

Dose 1

Dietary Supplement: 10G

20G STRB powder

EXPERIMENTAL

Dose 2

Dietary Supplement: 20G

40G STRB powder

EXPERIMENTAL

Dose 3

Dietary Supplement: 40G

PlacebonoFiber

PLACEBO COMPARATOR

Placebo without fiber

Dietary Supplement: Placebonofiber

Interventions

Placebo DIETARY_SUPPLEMENT

whole milk shake without strawberry powder served with the high fat/carbohydrate test meal

Also known as: Pbo

Placebo

10G DIETARY_SUPPLEMENT

whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal

Also known as: Dose 1

10G STRB powder

20G DIETARY_SUPPLEMENT

whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal

Also known as: Dose 2

20G STRB powder

40G DIETARY_SUPPLEMENT

whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal

Also known as: Dose 3

40G STRB powder

Placebonofiber DIETARY_SUPPLEMENT

Placebo without Fiber

PlacebonoFiber

Eligibility Criteria

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

You may qualify if:

• 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.
• 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 BACKGROUND

• Park 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.

  PMID: 26842771 DERIVED

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Inflammation; Insulin Resistance; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study had the following limitations: the study was single blinded and lack of data on other non-anthocyanin strawberry polyphenols and their metabolites may yield additional insight on the relationship between strawberry polyphenols \& bioactivity

Results Point of Contact

• Title: Britt Burton-Freeman
• Organization: Illinois Institute of Techology

bburton@iit.edu

708-341-0178

Study Officials

• Indika Edirisinghe, PhD

  Institute for Food Safety and Health

  PRINCIPAL INVESTIGATOR

• Britt Burton-Freeman, PhD, MS

  Institute for Food Safety and Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: September 15, 2010
• Primary Completion: October 15, 2015
• Study Completion: October 15, 2015
• Last Updated: February 12, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)