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The Cholesterol Lowering Effects of Strawberry (STR4)

Primary Purpose

Hypercholesterolemia, Glycemic Response

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Treatment Beverage
Placebo Treatment Beverage
Sponsored by
Clinical Nutrition Research Center, Illinois Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring Nutrition, Polyphenols, Berries, Lipid Panels

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and post-menopausal women (without menses for 1 year) with moderate hypercholesterolemia as defined by LDL cholesterol between 115mg/dl-165mg/dl and total cholesterol >160mg/dl preferred but not to exceed 240mg/dl
  • 40-69 years of age
  • Body Mass Index (BMI) range from 25 to 38.9 kg/m2
  • Nonsmoker
  • No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc…
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol
  • Weight stable: not gained or lost weight +/- 5 kg in previous 3 months

Exclusion Criteria:

  • Men and women who smoke
  • Past smokers: abstinence for minimum 2 years
  • Men and women with known or suspected food intolerance, allergies or hypersensitivity
  • Men and women known to have/diagnosed with diabetes mellitus
  • Men and women who have fasting blood glucose concentrations > 110mg/dL
  • Men and women who have uncontrolled blood pressure >120 mmHg/80 mmHg
  • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc...
  • Men and women with cancer other than non-melanoma skin cancer in previous 5 years
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are breast-feeding
  • Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
  • Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
  • Men and women who are vegans
  • Substance (alcohol or drug) abuse within the last 2 years
  • Excessive coffee and tea consumers (> 4 cups/d) and polyphenol consumers (>2 cups fresh/day
  • Men and women who do excessive exercise regularly or athlete
  • Unstable weight: gained or lost weight +/- 5 kg in previous 3 months
  • Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.

Sites / Locations

  • Clinical Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Treatment Beverage

Placebo Treatment Beverage

Arm Description

Strawberry

Placebo Beverage

Outcomes

Primary Outcome Measures

Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment.
plasma LDL cholesterol

Secondary Outcome Measures

Changes in endothelial function as measured by Flow Medicated Vasodilation (FMD) in 4-week intervention of strawberries vs control treatment.
endothelial function as measured by Flow Medicated Vasodilation (FMD)

Full Information

First Posted
November 17, 2015
Last Updated
January 25, 2021
Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02612090
Brief Title
The Cholesterol Lowering Effects of Strawberry
Acronym
STR4
Official Title
The Cholesterol Lowering Effects of Strawberry: A Randomized Controlled Trial Establishing Strawberry's Role in Cardiovascular Health
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
July 16, 2017 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary objective is to assess strawberry intake on LDL cholesterol and its association with atherosclerosis development.
Detailed Description
The trial is designed as a randomized, 2-arm, 2-sequence, within-subject, cross-over, chronic feeding study. The arms of the study will include regular consumption of a strawberry or strawberry-placebo powder equivalent to ~3.5 servings of strawberries/day (50g) freeze-dried strawberry powder (provided twice a day, 25 grams each time >6h apart). A planned sample size of 50 men and women will be enrolled into the study. This study will require one initial screening visit, 4 study visits, and 6 weekly visits. This study will take approximately 12 weeks per subject to complete. The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), fasting blood draw, and completion of a survey relate to general eating, health, and exercise habits. If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend day) will be instructed at the Screening Visit and collected before study day 1 to assess subjects' baseline dietary intake pattern. Subjects will be instructed to follow a strictly limited polyphenolic diet for 7 days prior to the study and throughout their participation time, while maintaining their usual diet pattern and physical activity, with counseling by staff investigator and/or Registered Dietitian. A dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit. Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health care professional will take a fasting blood draw with a butterfly needle. Subjects will be randomized to receive a placebo or treatment beverage based on randomized treatment sequences at 4 study visits. The sequences of receiving the beverage treatments at each visit will be randomly assigned to one of two of following sequences: placebo- treatment beverage or treatment beverage -placebo. Each study visit will involve blood sample collection at time points 0h (fasting) for assessment of change in plasma lipid and lipoprotein markers. Each study visit will involve a 2 flow mediated dilatation procedure to assess endothelial function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Glycemic Response
Keywords
Nutrition, Polyphenols, Berries, Lipid Panels

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment Beverage
Arm Type
Active Comparator
Arm Description
Strawberry
Arm Title
Placebo Treatment Beverage
Arm Type
Placebo Comparator
Arm Description
Placebo Beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Active Treatment Beverage
Other Intervention Name(s)
Active Comparator
Intervention Description
Strawberry
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Treatment Beverage
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment.
Description
plasma LDL cholesterol
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in endothelial function as measured by Flow Medicated Vasodilation (FMD) in 4-week intervention of strawberries vs control treatment.
Description
endothelial function as measured by Flow Medicated Vasodilation (FMD)
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Changes in plasma total cholesterol in 4-week intervention of strawberries vs control treatment.
Description
plasma total cholesterol
Time Frame
4 weeks
Title
Changes in plasma HDL cholesterol in 4-week intervention of strawberries vs control treatment.
Description
plasma HDL cholesterol
Time Frame
4 weeks
Title
Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment.
Description
plasma triglycerides
Time Frame
4 weeks
Title
Changes in plasma glucose in 4-week intervention of strawberries vs control treatment.
Description
plasma glucose
Time Frame
4 weeks
Title
Changes in plasma insulin in 4-week intervention of strawberries vs control treatment.
Description
plasma insulin
Time Frame
4 weeks
Title
Changes in plasma C-Reactive Protein in 4-week intervention of strawberries vs control treatment
Description
plasma C-Reactive Protein
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and post-menopausal women (without menses for 1 year) with moderate hypercholesterolemia as defined by LDL cholesterol between 115mg/dl-165mg/dl and total cholesterol >160mg/dl preferred but not to exceed 240mg/dl 40-69 years of age Body Mass Index (BMI) range from 25 to 38.9 kg/m2 Nonsmoker No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements, etc… Able to provide informed consent Able to comply and perform the procedures requested by the protocol Weight stable: not gained or lost weight +/- 5 kg in previous 3 months Exclusion Criteria: Men and women who smoke Past smokers: abstinence for minimum 2 years Men and women with known or suspected food intolerance, allergies or hypersensitivity Men and women known to have/diagnosed with diabetes mellitus Men and women who have fasting blood glucose concentrations > 110mg/dL Men and women who have uncontrolled blood pressure >120 mmHg/80 mmHg Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc... Men and women with cancer other than non-melanoma skin cancer in previous 5 years Women who are known to be pregnant or who are intending to become pregnant over the course of the study Women who are breast-feeding Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc... Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months. Men and women who are vegans Substance (alcohol or drug) abuse within the last 2 years Excessive coffee and tea consumers (> 4 cups/d) and polyphenol consumers (>2 cups fresh/day Men and women who do excessive exercise regularly or athlete Unstable weight: gained or lost weight +/- 5 kg in previous 3 months Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Britt Burton-Freeman, Ph.D
Organizational Affiliation
Illinois Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33758944
Citation
Huang L, Xiao D, Zhang X, Sandhu AK, Chandra P, Kay C, Edirisinghe I, Burton-Freeman B. Strawberry Consumption, Cardiometabolic Risk Factors, and Vascular Function: A Randomized Controlled Trial in Adults with Moderate Hypercholesterolemia. J Nutr. 2021 Jun 1;151(6):1517-1526. doi: 10.1093/jn/nxab034.
Results Reference
derived

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The Cholesterol Lowering Effects of Strawberry

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