Clinical trial NCT03441620: The Effects of Strawberries on Blood Cholesterol.
Official title: Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyper-LDL-cholesterolemia
Metabolic Syndrome
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
name: Oklahoma State University
First posted: 2018-02-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Lipid profiles
timeFrame: 14 weeks
measure: Glycemic control
timeFrame: 14 weeks
measure: Serum lipid particle concentrations
timeFrame: 14 weeks
measure: Diabetes control
timeFrame: 14 weeks
Secondary outcomes:
measure: Systemic Inflammation
timeFrame: 14 weeks
measure: Systemic Anthocyanins
timeFrame: 14 weeks
measure: Serum metabolomics
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada at Las Vegas
state: Nevada
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center, OCTSI
state: Oklahoma
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
affiliation: University of Nevada at Las Vegas
name: Arpita Basu, PHD
role: PRINCIPAL_INVESTIGATOR
References: