The Effects of Strawberries on Blood Cholesterol. | NCT03441620

Studies
The Effects of Strawberries on Blood Cholesterol.

NCT03441620

Sponsor

University of Nevada, Las Vegas

Status

Completed

Last Update Posted

Mar 16, 2021Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Hyper-LDL-cholesterolemia
Metabolic Syndrome

Interventions

strawberries
Control powder

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jan 31, 2021Actual

Completion Date

Jan 31, 2021Actual

First Submitted Date

Feb 5, 2018

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2021

Last Update Posted Date

Mar 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arpita Basu, Associate Professor, University of Nevada, Las VegasPrincipal Investigator

Lead Sponsor

University of Nevada, Las VegasOTHER

Collaborators

Name	Class
University of Oklahoma	OTHER
Oklahoma State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	Calorie and fiber-matched control powder	Other: Control powder
Strawberry one serving	Experimental	Freeze-dried powder equivalent to one serving fresh strawberries per day.	Dietary Supplement: strawberries
Strawberry two-half servings	Experimental	Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.	Dietary Supplement: strawberries

Interventions

Name	Type	Description	Arm Group Labels	Other Names
strawberries	Dietary Supplement	Freeze-dried strawberry powder	Strawberry one serving Strawberry two-half servings

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum Lipid profiles	Serum LDL, total and HDL cholesterol, triglycerides	14 weeks
Glycemic control	Blood glucose	14 weeks
Serum lipid particle concentrations	Molar concentrations of serum lipids and particle size	14 weeks
Diabetes control	Insulin resistance	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
Systemic Inflammation	Serum C-reactive protein and adipokines	14 weeks
Systemic Anthocyanins	Strawberry anthocyanin metabolites measured in serum

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arpita Basu, PHD	University of Nevada at Las Vegas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nevada at Las Vegas		Las Vegas	Nevada	89154	United States
University of Oklahoma Health Sciences Center, OCTSI

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided