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The Effects of Strawberries on Blood Cholesterol.

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ClinicalTrials.gov Identifier: NCT03441620
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
University of Oklahoma
Information provided by (Responsible Party):
Arpita Basu, University of Nevada, Las Vegas

Brief Summary:
In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.

Condition or disease Intervention/treatment Phase
Hyper-LDL-cholesterolemia Metabolic Syndrome Dietary Supplement: strawberries Other: Control powder Not Applicable

Detailed Description:

Screening and consenting: Any interested participant will be screened via a telephone call, and based on this information, participants will then be scheduled for the screening visit, consented and enrolled in the study. The screen forms have been attached to the protocol. For those who do not qualify, screen forms will be immediately destroyed. The screen visit will involve an 8 hour fasting state and the following procedures:

  • 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, 8, and 12 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 (to be hired)]. 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. These values will be calculated using a Microsoft excel spreadsheet for each participant. Screening tests will include clinical laboratory tests for blood glucose, lipids, C-reactive protein and metabolic panel to determine eligibility in the study

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Calorie and fiber-matched control powder
Other: Control powder
Control powder matched for fiber and strawberries

Experimental: Strawberry one serving
Freeze-dried powder equivalent to one serving fresh strawberries per day.
Dietary Supplement: strawberries
Freeze-dried strawberry powder

Experimental: Strawberry two-half servings
Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.
Dietary Supplement: strawberries
Freeze-dried strawberry powder




Primary Outcome Measures :
  1. Serum Lipid profiles [ Time Frame: 12 months ]
    Serum LDL, TOTAL and HDL cholesterol, triglycerides all in mg/dL


Secondary Outcome Measures :
  1. Systemic Inflammation [ Time Frame: 12 months ]
    Serum C-reactive protein, interleukins all in ng/mL

  2. Systemic Anthocyanins [ Time Frame: 12 months ]
    Strawberry anthocyanin metabolites measured in serum



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elevated total and LDL cholesterol
  • features of the metabolic syndrome

Exclusion Criteria:

  • previous history of adverse CVD events
  • allergic to strawberries
  • pregnant and/or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441620


Contacts
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Contact: Arpita Basu, PHD 7028954576 arpita.basu@unlv.edu

Locations
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United States, Nevada
University of Nevada at Las Vegas Recruiting
Las Vegas, Nevada, United States, 89154
Contact: Arpita Basu, PhD         
United States, Oklahoma
University of Oklahoma Health Sciences Center, OCTSI Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Hal Scofield, MD         
Sponsors and Collaborators
University of Nevada, Las Vegas
University of Oklahoma
Investigators
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Principal Investigator: Arpita Basu, PHD University of Nevada at Las Vegas

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Responsible Party: Arpita Basu, Associate Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT03441620     History of Changes
Other Study ID Numbers: 1119274
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases