Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins

Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Juice Plus+(R)

Detailed Description

Phytonutrients are regarded to play an important role in many health-related issues like:

• Improvement of redox balance
• Anti-inflammatory effects
• Prevention of chronic diseases like CVD, stroke, diabetes II, Alzheimer´s, AMD, and certain forms of cancer
• Beneficial effects on human´s microbiome Therefore it is of scientific interest whether this product provides absorbable phytonutrients/phenolics and vitamins to support mechanistic explanations for the beneficial outcomes observed in the past after intake of Juice Plus+®.

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

MERITS

• This study would reveal knowledge whether and to which extent specific vitamins and phenolic compounds are absorbed, including absorption kinetics/metabolism.
• Data of this study may provide support for mechanistic arguments on the beneficial clinical outcomes observed and published in the past.

ENDPOINTS

• Absorption kinetics of phenolic compounds in plasma
• Bioavailability of vitamins C, E, and carotenoids into plasma

Absorption kinetics of phytonutrients:

• Open-, one-arm study, absorption kinetics over 10 hours
• 5 blood sample collections: baseline (= 0); 1hr, 2hrs, 5hrs and 10 hours after intake of 3 capsules
• Wash-out of all food supplements and dietetic foodstuff: 2 weeks
• Wash-out of phytonutrients: 48 hours before baseline sampling, accomplished via a phytonutrient-poor diet.

Bioavailability of vitamins C, E, A and carotenoids:

• Open-, one-arm study over 8 weeks
• 2 blood sample collections: at baseline (2 weeks after the phenolics experiment) and after 8-weeks
• Wash-out of all food supplements and dietetic foodstuff: 4 weeks, 2 weeks before the phenolics experiment + another 2 weeks Subjects: 20 healthy subjects from Graz region, meeting all inclusion criterions (see underneath).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8042
    • Green Beat
  • Styria
    • Graz, Styria, Austria, 8010
      • Institute of Pathophysiology and Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 20 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.

Exclusion Criteria:

• all people not meeting the inclusion criterions;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Juice Plus+(R); Check of phenolic absorption between baseline and after 8wks of intake before-after comparison	Dietary supplement: Juice Plus+(R); before-after comparison of plasma phenolics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0	Two weeks after the first blood drawings, for the phytonutrient absorption and absorption kinetics, subjects will be invited to another visit to the laboratory. During these two weeks the volunteers adhere to the wash-out from all food supplements. After an overnight fast they come to the lab for the baseline blood drawings to evaluate vitamins and carotenoids absorption. This procedure will be repeated after 8 weeks of supplementation with 6 capsules of Juice Plus+® per day (~2.2g juice powder per day). During this time subjects will be instructed to maintain their habitual diet.	1 year

Collaborators and Investigators

• Sponsor: Green Beat
• Collaborators: Medical University of Graz
• Investigators: Principal Investigator: Manfred Lamprecht, PhD, Green Beat + Medical University of Graz

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 29, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: absorption; phenolics; fruit & vegetable concentrate; Bioavailability of phenolic compounds
• Other Study ID Numbers: 27-507 ex 14/15