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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03441620
Other study ID # 1119274
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date January 31, 2021

Study information

Verified date March 2021
Source University of Nevada, Las Vegas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date January 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - elevated total and LDL cholesterol (>116 mg/dL) - body mass index (> or = 30 kg/m2) - features of the metabolic syndrome Exclusion Criteria: - taking glucose and lipid lowering medications (e.g. statins, metformin) - history of chronic conditions (diabetes, CHD, anemia, renal diseases) - allergic to strawberries - pregnant and/or lactating - smoking - vegetarian or consuming special diet

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
strawberries
Freeze-dried strawberry powder
Other:
Control powder
Control powder matched for fiber and strawberries

Locations

Country Name City State
United States 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

Sponsors (3)

Lead Sponsor Collaborator
University of Nevada, Las Vegas Oklahoma State University, University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Lipid profiles Serum LDL, total and HDL cholesterol, triglycerides 14 weeks
Primary Glycemic control Blood glucose 14 weeks
Primary Serum lipid particle concentrations Molar concentrations of serum lipids and particle size 14 weeks
Primary Diabetes control Insulin resistance 14 weeks
Secondary Systemic Inflammation Serum C-reactive protein and adipokines 14 weeks
Secondary Systemic Anthocyanins Strawberry anthocyanin metabolites measured in serum 14 weeks
Secondary Serum metabolomics primary and lipid metabolites in serum 14 weeks
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