Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2018-02-01
2021-01-31
Brief Summary
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Detailed Description
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* Completing screening questionnaire
* Measuring height, weight, blood pressure, and waist size
* Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel \[PI \&Co-PI: Basu, Izuora and graduate student\]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Control
Calorie and fiber-matched control powder
Control powder
Control powder matched for fiber and strawberries
Strawberry one serving
Freeze-dried powder equivalent to one serving fresh strawberries per day.
strawberries
Freeze-dried strawberry powder
Strawberry two-half servings
Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.
strawberries
Freeze-dried strawberry powder
Interventions
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strawberries
Freeze-dried strawberry powder
Control powder
Control powder matched for fiber and strawberries
Eligibility Criteria
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Inclusion Criteria
* body mass index (\> or = 30 kg/m2)
* features of the metabolic syndrome
Exclusion Criteria
* history of chronic conditions (diabetes, CHD, anemia, renal diseases)
* allergic to strawberries
* pregnant and/or lactating
* smoking
* vegetarian or consuming special diet
18 Years
65 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Oklahoma State University
OTHER
University of Nevada, Las Vegas
OTHER
Responsible Party
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Arpita Basu
Associate Professor
Principal Investigators
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Arpita Basu, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Nevada at Las Vegas
Locations
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University of Nevada at Las Vegas
Las Vegas, Nevada, United States
University of Oklahoma Health Sciences Center, OCTSI
Oklahoma City, Oklahoma, United States
Oklahoma State University
Stillwater, Oklahoma, United States
Countries
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Other Identifiers
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1119274
Identifier Type: -
Identifier Source: org_study_id
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