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Matrix on Fruit Constituent Bioavailability (FRT)

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ClinicalTrials.gov Identifier: NCT01908634
Recruitment Status : Active, not recruiting
First Posted : July 25, 2013
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States

Brief Summary:
Primary objective is to evaluate the influence of matrix on the bioavailability of key phytochemical constituents in fruits and their subsequent effect on chronic disease risk factors.

Condition or disease Intervention/treatment Phase
Healthy Non-smoker Dietary Supplement: Milk-based Strawberry Beverage Dietary Supplement: Water-Based Strawberry Beverage Dietary Supplement: Milk-based Fruit-Mixed Beverage Dietary Supplement: Water-Based Fruit-Mixed Beverage Not Applicable

Detailed Description:

This study is a single-center, randomized, cross-over, 4-arm, single- blinded, 6-hour postprandial study to evaluate the effects of strawberry or comparator fruit provided in a formulated beverage with milk (as the base) or water or fresh/pureed.

A planned sample size of 10 men and women will be recruited into the study. Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online and clinic screening mechanisms, including questionnaires, fasting glucose concentration, and anthropometric measurements. Eligible subjects will be invited to participate in the study. Subjects will begin by completing a 3-day pre-study assessment of their usual dietary intake using 3-day food diary. After reviewing baseline food records, subjects will be instructed to avoid polyphenolic-containing foods for 2 days prior to the study visit, while maintaining their usual diet pattern and physical activity.

Subjects will participate in 6 h postprandial study days. Subjects will be randomized on the first day of starting the first post prandial visit day.

For each 6 h postprandial study visit, subjects will arrive fasted and follow procedures published by our lab previously. This includes: pre-study evaluation for compliance (fasting, dinner consumption, limited polyphenol intake) and readiness for study visit, catheter placement by registered nurse, fasting blood sample, consumption of high fat/carbohydrate meal accompanied by 1 of the treatment beverages, subsequent blood sampling from catheter [ ~1 tablespoon (12ml)] at designated time points for 6 hours.

Each postprandial study visit day will last approximately 7 hours and subjects will be required to remain at the Clinical Nutrition Research Center at the Illinois Institute of Technology main campus for the duration of the visit. The visit procedures are repeated four times ~ 1 week apart to accommodate subject testing with all four beverages; all procedures are identical on each postprandial study test visit with the exception that only an assigned test beverage per each visit will be consumed with the breakfast.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Pilot Study to Test the Effects of Matrix on Fruit Constituent Bioavailability and Influence on Chronic Disease Risk Factors.
Actual Study Start Date : July 1, 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Milk-based Strawberry Beverage
Strawberry beverage with milk
Dietary Supplement: Milk-based Strawberry Beverage
Experimental: Water-based Strawberry Beverage
Strawberry beverage with water
Dietary Supplement: Water-Based Strawberry Beverage
Active Comparator: Milk-based Fruit-mixed Beverage
Fruit-Mixed beverage with milk
Dietary Supplement: Milk-based Fruit-Mixed Beverage
Experimental: Water-based Fruit-Mixed Beverage
Fruit-Mixed beverage with Water
Dietary Supplement: Water-Based Fruit-Mixed Beverage



Primary Outcome Measures :
  1. Changes in polyphenol anthocyanin concentrations [ Time Frame: 6 hours ]
    Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect, iAUC, total AUC, Cmax and TMax


Secondary Outcome Measures :
  1. Changes in insulin concentrations [ Time Frame: 6 hours ]
    Changes in Plasma insulin concentrations during the acute phases (from 0 to 6 hrs) and over the chronic phase, assessed by time and treatment effect, iAUC, total AUC, Cmax and TMax


Other Outcome Measures:
  1. Changes in Plasma cholesterol Concentrations (LDL, Triglycerides, and Total Cholesterol) [ Time Frame: Postprandial 6 hours ]
    Changes in Plasma cholesterol concentrations (LDL, triglycerides, and total cholesterol)over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect, iAUC

  2. Changes in plasma glucose concentrations [ Time Frame: Postprandial 6 hours ]
    Changes in Plasma glucose concentrations over 6hr (from 0 to 6 hrs), assessed by time and treatment effect, iAUC, total AUC, Cmax and TMax



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (18-78 years of age)
  • Relatively healthy
  • Non-smoker or past smoker with abstinence for at least 2 years

Exclusion Criteria:

  • Pregnant and/or breast feeding
  • Smoker or past smoker with abstinence <2 years
  • Allergy or intolerance to study foods
  • Current regular consumption of berries is > 2 servings per day.
  • Fasting blood glucose ≥ 126 mg/dL. Subjects identified with elevated fasting blood glucose levels will be advised to contact their primary care physician for appropriate follow-up care.
  • Taking over the counter antioxidant supplements or other supplements that may interfere with the study procedures or endpoints.
  • Subjects with unusual dietary habits (e.g. pica).
  • Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 lbs in a 60 day period).
  • Excessive exercisers or trained athletes.
  • Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, or other systemic diseases.
  • Addicted to drugs and/or alcohol.
  • Medically documented psychiatric or neurological disturbances.
  • Severe obesity as defined by >39.9 BMI or under weight for height (BMI <18.5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908634


Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Investigators
Principal Investigator: Britt Burton-Freeman, Ph.D Illinois Institute of Technology

Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT01908634     History of Changes
Other Study ID Numbers: 2013-076
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Institute for Food Safety and Health, United States:
Bioavailability
Strawberry polyphenols
Fruit Beverage Matrix