The Effects of Strawberries on Blood Cholesterol.

Metabolic Syndrome Clinical Trial

Official title:

Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441620
• Other study ID #: 1119274
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hyper-LDL-cholesterolemia
• Metabolic Syndrome
• Syndrome

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