NCT03596008

Acute Strawberry Intake on Endothelial Function

A Pilot Study Investigating the Effect of Acute Strawberry Intake on Endothelial Function Measured by Flow Mediated Dilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of the study are (1) to evaluate the effects of acute dietary strawberry intake on measures of vascular function in healthy adults following a meal challenge, (2) to evaluate the effects of acute dietary strawberry intake on metabolic status, and (3) to assess intervention-associated metabolite and inflammatory signatures and their relationship to vascular function.

Detailed description

This study is a randomized, 2-arm, single-blinded, within subject cross-over trial focused on evaluating the effects of acute dietary strawberry intake on measures of vascular function, metabolic status, as well as metabolite and inflammatory signatures and their relationship to vascular function in healthy adults following a meal challenge. A planned sample size of 15 will be enrolled into the study. This study will require one initial screening visit and 2 study visits. This study will take approximately 1 week 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), and completion of a survey relate to general eating, health, and exercise habits. If willing and eligible to participate, subjects will be invited to participate in the study for 2 study days. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration. 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 and ultrasound measurement 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 place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. A baseline FMD procedure will be completed immediately after baseline blood sample collection. Afterwards, subjects will be randomized to receive the strawberry powder treatment or placebo based on randomized treatment sequences for 2 study visits immediately after fasting blood draw. The sequences of receiving the supplement at each visit will be randomly assigned to one of 2 following sequences: A-B or B-A Each study visit will involve with blood samples collection at time points 0 (fasting), 1, 2, 4, 6, and 24 hour (h) for assessment of change in metabolites and inflammatory signatures. FMD procedure will be conducted after completing the baseline blood draw and later at 2h, 4h, 6h, and 24h. A standard breakfast will be provided immediately after the 0h blood collection.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active drink	The freeze-dried strawberry powder (25 g) in active drink
DIETARY_SUPPLEMENT	Placebo drink	Placebo drink

Timeline

• Start date: 2018-07-20
• Primary completion: 2020-10-12
• Completion: 2020-10-12
• First posted: 2018-07-23
• Last updated: 2021-07-27

Locations

1 site across 1 country: United States