Trial Outcomes & Findings for Matrix on Fruit Constituent Bioavailability (NCT NCT01908634)

NCT ID: NCT01908634

Last Updated: 2021-02-11

Results Overview

Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2021-02-11

Participant Flow

Relatively healthy individuals were screened and recruited in Chicago, IL for the study at the Clinical Nutrition Research Center (CNRC) from 2013 to 2014

Eligible participants followed a low polyphenol diet 3 days before each test day visit (3 days run-in), while maintaining their usual diet and physical activity patterns.

Participant milestones

Measure	All Participants All participants received multiple interventions in \*1\* sequence (i.e., Water-based Strawberry Beverage With Meal first, then Milk-based Strawberry Beverage With Meal, then Water-based Strawberry Beverage Without Meal, then Milk-based Strawberry Beverage Without Meal)
Milk-based Strawberry Beverage With Meal STARTED	10
Milk-based Strawberry Beverage With Meal COMPLETED	10
Milk-based Strawberry Beverage With Meal NOT COMPLETED	0
Water-based Strawberry Beverage Wit Meal STARTED	10
Water-based Strawberry Beverage Wit Meal COMPLETED	9
Water-based Strawberry Beverage Wit Meal NOT COMPLETED	1
Milk-based Strawberry Beverage w/o Meal STARTED	9
Milk-based Strawberry Beverage w/o Meal COMPLETED	4
Milk-based Strawberry Beverage w/o Meal NOT COMPLETED	5
Water-based Strawberry Beverage w/o Meal STARTED	4
Water-based Strawberry Beverage w/o Meal COMPLETED	4
Water-based Strawberry Beverage w/o Meal NOT COMPLETED	0

Reasons for withdrawal

Measure	All Participants All participants received multiple interventions in \*1\* sequence (i.e., Water-based Strawberry Beverage With Meal first, then Milk-based Strawberry Beverage With Meal, then Water-based Strawberry Beverage Without Meal, then Milk-based Strawberry Beverage Without Meal)
Water-based Strawberry Beverage Wit Meal Withdrawal by Subject	1
Milk-based Strawberry Beverage w/o Meal Withdrawal by Subject	5

Baseline Characteristics

Matrix on Fruit Constituent Bioavailability

Baseline characteristics by cohort

Measure	All Participants n=9 Participants All participants, measured at screening visit
Age, Continuous All	24.5 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Nine subjects completed Part 1 (beverage with meal) and a subset of 4 completed Part 2 (beverages without meal).

Changes in Plasma polyphenol anthocyanin concentrations over 6 hr (from 0 to 6 hrs), assessed by time and treatment effect Cmax

Outcome measures

Measure	Milk-based Strawberry Beverage no Meal n=4 Participants Milk-based Strawberry beverage without meal Milk-based Strawberry Beverage without meal	Water-based Strawberry Beverage no Meal n=4 Participants Water-based Strawberry beverage without meal Water-Based Strawberry Beverage without meal	Milk-based Strawberry Beverage With Meal n=9 Participants Milk-based Strawberry beverage with meal Milk-based strawberry Beverage with meal	Water-based Strawberry Beverage With Meal n=9 Participants Water-based Strawberry beverage with meal Water-Based strawberry Beverage with meal
CMax in Polyphenol Anthocyanin Concentrations	8.7 nmol/L Standard Error 0.7	22.1 nmol/L Standard Error 3.8	7.6 nmol/L Standard Error 1.5	11.3 nmol/L Standard Error 2.7

Adverse Events

Without Meal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

With Meal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Britt Burton-Freeman

Illinois Institute of Techology

Phone: 708-341-0178

Email: bburton@iit.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place