Acute Strawberry Intake on Endothelial Function

NCT03596008 | Completed

• 1 other identifier: IRB2018-065
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

strawberry; monocytes; endothelial function

Outcome Measures

Primary Outcomes (1)

• Changes in postprandial endothelial function using Flow Mediated Dilation (FMD) between 2 treatments

  postprandial endothelial function using Flow Mediated Dilation (FMD)

  Baseline to 6 hours

Secondary Outcomes (2)

• Change in plasma blood glucose concentration response between 2 treatments

  Baseline to 24 hours

• Change in plasma blood insulin concentration response between 2 treatments

  Baseline to 24 hours

Other Outcomes (2)

• Changes in plasma polyphenol metabolites between 2 treatments

  Baseline to 24 hours

• Changes in plasma inflammation (monocytes isolation) responses between 2 treatments

  Baseline to 24 hours

Study Arms (2)

Active1

EXPERIMENTAL

freeze-dried strawberry powder (25 g) in active drink

Dietary Supplement: Active drink

Placebo

PLACEBO COMPARATOR

Placebo drink

Dietary Supplement: Placebo drink

Interventions

Active drink DIETARY_SUPPLEMENT

The freeze-dried strawberry powder (25 g) in active drink

Also known as: 25g strawberry drink

Active1

Placebo drink DIETARY_SUPPLEMENT

Placebo drink

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) between 20 to 35 kg/m2
• Aged 18-45 years old
• Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trail
• Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests
• Able to provide informed consent and comply with study procedures

You may not qualify if:

• Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped \>2 years
• Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders that may interfere with study outcomes
• Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
• Taking any medications and/or supplements that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, etc),
• Unstable use of any medication/supplement
• Have a history of cancer, except for non-melanoma skin cancer within past 5 years
• Addicted to drugs and/or alcohol (\>4 drinks/day)
• Have been exposed to any non-registered drug product within last 30 days.
• Working overnight (e.g. 3rd shift of overnight workers)
• Excessive exercisers or trained athletes
• Have allergies/intolerances to strawberries
• Extreme dietary habits (ie. vegetarian/vegan)
• Excessive coffee/tea drinker (\>4 cups/day)
• Actively losing weight/ trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months)
• Donated blood within last 3 months

Sponsors & Collaborators

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

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: July 20, 2018
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)