Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02612090
Study type Interventional
Source Clinical Nutrition Research Center, Illinois Institute of Technology
Contact
Status Completed
Phase N/A
Start date January 4, 2016
Completion date October 31, 2018

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 NCT01941836 - Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients Phase 2
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
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 NCT01670734 - Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects Phase 1
Completed NCT01678521 - Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients N/A
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 NCT01478789 - Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans N/A
Completed NCT01768403 - Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia N/A
Completed NCT01575171 - Using Nudges to Implement Comparative Effectiveness N/A