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The Cholesterol Lowering Effects of Strawberry (STR4)

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ClinicalTrials.gov Identifier: NCT02612090
Recruitment Status : Active, not recruiting
First Posted : November 23, 2015
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States

Brief Summary:
Primary objective is to assess strawberry intake on LDL cholesterol and its association with atherosclerosis development.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Glycemic Response Dietary Supplement: Active Treatment Beverage Dietary Supplement: Placebo Treatment Beverage Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Cholesterol Lowering Effects of Strawberry: A Randomized Controlled Trial Establishing Strawberry's Role in Cardiovascular Health
Actual Study Start Date : January 4, 2016
Estimated Primary Completion Date : May 4, 2019
Estimated Study Completion Date : May 4, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active Treatment Beverage
Strawberry
Dietary Supplement: Active Treatment Beverage
Strawberry
Other Name: Active Comparator
Placebo Comparator: Placebo Treatment Beverage
Placebo Beverage
Dietary Supplement: Placebo Treatment Beverage
Placebo
Other Name: Placebo Comparator



Primary Outcome Measures :
  1. Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Changes in endothelial function as measured by Flow Medicated Vasodilation (FMD) in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]

Other Outcome Measures:
  1. Changes in plasma total cholesterol in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
  2. Changes in plasma HDL cholesterol in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
  3. Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
  4. Changes in plasma glucose in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
  5. Changes in plasma insulin in 4-week intervention of strawberries vs control treatment. [ Time Frame: 4 weeks ]
  6. Changes in plasma C-Reactive Protein in 4-week intervention of strawberries vs control treatment [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612090


Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Investigators
Principal Investigator: Britt Britt Burton-Freeman, Ph.D Illinois Institute of Technology

Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT02612090     History of Changes
Other Study ID Numbers: IRB2015-058
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institute for Food Safety and Health, United States:
Nutrition
Polyphenols
Berries
Lipid Panels

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases