Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02612090
Other study ID # IRB2015-058
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2016
Est. completion date October 31, 2018

Study information

Verified date January 2021
Source Clinical Nutrition Research Center, Illinois Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date October 31, 2018
Est. primary completion date July 16, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 69 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Active Treatment Beverage
Strawberry
Placebo Treatment Beverage
Placebo

Locations

Country Name City State
United States Clinical Nutrition Research Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Clinical Nutrition Research Center, Illinois Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in plasma total cholesterol in 4-week intervention of strawberries vs control treatment. plasma total cholesterol 4 weeks
Other Changes in plasma HDL cholesterol in 4-week intervention of strawberries vs control treatment. plasma HDL cholesterol 4 weeks
Other Changes in plasma triglycerides in 4-week intervention of strawberries vs control treatment. plasma triglycerides 4 weeks
Other Changes in plasma glucose in 4-week intervention of strawberries vs control treatment. plasma glucose 4 weeks
Other Changes in plasma insulin in 4-week intervention of strawberries vs control treatment. plasma insulin 4 weeks
Other Changes in plasma C-Reactive Protein in 4-week intervention of strawberries vs control treatment plasma C-Reactive Protein 4 weeks
Primary Changes in plasma LDL cholesterol in 4-week intervention of strawberries vs control treatment. plasma LDL cholesterol 4 weeks
Secondary 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) 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Recruiting NCT03947866 - Ezetimibe-Rosuvastatin Evaluation Study
Completed NCT01709513 - Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) Phase 3
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02550288 - A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383) Phase 3
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT04485793 - Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia N/A
Completed NCT02341924 - Validating the "Foods for Health" Portfolio of Functional Food Products N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Completed NCT01941836 - Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients Phase 2
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01678521 - Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients N/A
Completed NCT01670734 - Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects Phase 1
Completed NCT01370590 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1) Phase 3
Completed NCT01370603 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) Phase 3
Completed NCT01768403 - Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia N/A
Completed NCT01575171 - Using Nudges to Implement Comparative Effectiveness N/A
Completed NCT01446679 - Special Drug Use-Results Survey of Lipitor Tablets N/A