The Effects of Strawberries on Blood Cholesterol.
Primary Purpose
Hyper-LDL-cholesterolemia, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
strawberries
Control powder
Sponsored by
About this trial
This is an interventional treatment trial for Hyper-LDL-cholesterolemia
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
Sites / Locations
- University of Nevada at Las Vegas
- University of Oklahoma Health Sciences Center, OCTSI
- Oklahoma State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control
Strawberry one serving
Strawberry two-half servings
Arm Description
Calorie and fiber-matched control powder
Freeze-dried powder equivalent to one serving fresh strawberries per day.
Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.
Outcomes
Primary Outcome Measures
Serum Lipid profiles
Serum LDL, total and HDL cholesterol, triglycerides
Glycemic control
Blood glucose
Serum lipid particle concentrations
Molar concentrations of serum lipids and particle size
Diabetes control
Insulin resistance
Secondary Outcome Measures
Systemic Inflammation
Serum C-reactive protein and adipokines
Systemic Anthocyanins
Strawberry anthocyanin metabolites measured in serum
Serum metabolomics
primary and lipid metabolites in serum
Full Information
NCT ID
NCT03441620
First Posted
February 5, 2018
Last Updated
March 12, 2021
Sponsor
University of Nevada, Las Vegas
Collaborators
University of Oklahoma, Oklahoma State University
1. Study Identification
Unique Protocol Identification Number
NCT03441620
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas
Collaborators
University of Oklahoma, Oklahoma State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyper-LDL-cholesterolemia, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Calorie and fiber-matched control powder
Arm Title
Strawberry one serving
Arm Type
Experimental
Arm Description
Freeze-dried powder equivalent to one serving fresh strawberries per day.
Arm Title
Strawberry two-half servings
Arm Type
Experimental
Arm Description
Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
strawberries
Intervention Description
Freeze-dried strawberry powder
Intervention Type
Other
Intervention Name(s)
Control powder
Intervention Description
Control powder matched for fiber and strawberries
Primary Outcome Measure Information:
Title
Serum Lipid profiles
Description
Serum LDL, total and HDL cholesterol, triglycerides
Time Frame
14 weeks
Title
Glycemic control
Description
Blood glucose
Time Frame
14 weeks
Title
Serum lipid particle concentrations
Description
Molar concentrations of serum lipids and particle size
Time Frame
14 weeks
Title
Diabetes control
Description
Insulin resistance
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Systemic Inflammation
Description
Serum C-reactive protein and adipokines
Time Frame
14 weeks
Title
Systemic Anthocyanins
Description
Strawberry anthocyanin metabolites measured in serum
Time Frame
14 weeks
Title
Serum metabolomics
Description
primary and lipid metabolites in serum
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arpita Basu, PHD
Organizational Affiliation
University of Nevada at Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada at Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States
Facility Name
University of Oklahoma Health Sciences Center, OCTSI
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States
12. IPD Sharing Statement
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The Effects of Strawberries on Blood Cholesterol.
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