NCT02587468

Brief Summary

GOAL To identify absorption kinetics and bioavailability of phenolic compounds and specific vitamins from encapsulated Juice Plus+® powder ENDPOINTS

  • Absorption kinetics of phenolic compounds in plasma
  • Bioavailability of vitamins C, E, and carotenoids into plasma Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1.7 years

First QC Date

October 22, 2015

Last Update Submit

July 29, 2017

Conditions

Keywords

phenolicsabsorptionfruit & vegetable concentrateBioavailability of phenolic compounds

Outcome Measures

Primary Outcomes (1)

  • Absorption kinetics of phenolic acids after 1, 2, 5 and 10 hours, measured via HPLC, evaluated by repeated measures ANOVA, and assessed via SPSS 19.0.

    For the phenolics analyses subjects come to the lab after an overnight fast, and after 2 weeks wash-out of all food supplements and 48 hours wash-out of phytonutrients (phytonutrient-poor diet). To adhere to the phytonutrient-poor diet they receive an exact diet plan in the forefront. This plan will be perused with the research associate. After the baseline blood drawing, they receive 3 capsules of Juice Plus+® consumed with 250ml plain water from the pipe. They will be instructed to swallow one capsule of each blend (fruit, berry, vegetable). During this day 4 additional blood samples will be drawn: 1hr, 2hrs, 5hrs, 10hrs after capsule intake in the morning. After the 2hrs blood sampling the subjects get a standardized, phytonutrient-poor snack: white bread, cheese, ham, milk and water ad libitum. Subjects will receive a list with suggestions of allowed food they could consume on this day.

    1 year

Secondary Outcomes (1)

  • Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0

    1 year

Study Arms (1)

Juice Plus+(R)

EXPERIMENTAL

Check of phenolic absorption between baseline and after 8wks of intake before-after comparison

Dietary Supplement: Juice Plus+(R)

Interventions

Juice Plus+(R)DIETARY_SUPPLEMENT

before-after comparison of plasma phenolics

Juice Plus+(R)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men and women, 20-50 years old;
  • non-smokers;
  • BMI \>20 und \<30 kg/m2;
  • no medication;
  • premenopausal;
  • normal dietary habits (no specific diets, meals, food components etc.);
  • adherence to wash-out period.

You may not qualify if:

  • diet: subjects consuming \>4 servings of fruits and vegetables per day;
  • subjects with any kind of food allergy or histamine intolerance;
  • highly trained subjects (\> 5 training units/week);
  • women with menstrual dysfunctions;
  • pregnancy
  • alcoholics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Pathophysiology and Immunology

Graz, Styria, 8010, Austria

Location

Green Beat

Graz, 8042, Austria

Location

Study Officials

  • Manfred Lamprecht, PhD

    Green Beat + Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2015

First Posted

October 27, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations