The Cholesterol Lowering Effects of Strawberry

NCT02612090 | Completed

• 1 other identifier: IRB2015-058
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolemia; Glycemic Response

Keywords

Nutrition; Polyphenols; Berries; Lipid Panels

Outcome Measures

Primary Outcomes (1)

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

  plasma LDL cholesterol

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Other Outcomes (6)

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

  4 weeks

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

  4 weeks

• Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment.

  4 weeks

Study Arms (2)

Active Treatment Beverage

ACTIVE COMPARATOR

Strawberry

Dietary Supplement: Active Treatment Beverage

Placebo Treatment Beverage

PLACEBO COMPARATOR

Placebo Beverage

Dietary Supplement: Placebo Treatment Beverage

Interventions

Active Treatment Beverage DIETARY_SUPPLEMENT

Strawberry

Also known as: Active Comparator

Active Treatment Beverage

Placebo Treatment Beverage DIETARY_SUPPLEMENT

Placebo

Also known as: Placebo Comparator

Placebo Treatment Beverage

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

• 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.

  PMID: 33758944 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Britt Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 23, 2015
• Study Start: January 4, 2016
• Primary Completion: July 16, 2017
• Study Completion: October 31, 2018
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)