Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins

NCT ID: NCT02587468

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-07-31

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).

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).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Juice Plus+(R)

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

Group Type: EXPERIMENTAL

Juice Plus+(R)

Intervention Type: DIETARY_SUPPLEMENT

before-after comparison of plasma phenolics

Interventions

Juice Plus+(R)

before-after comparison of plasma phenolics

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: collaborator

Green Beat

OTHER

Sponsor Role: lead

Responsible Party

Lamprecht Manfred PhD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manfred Lamprecht, PhD

Role: PRINCIPAL_INVESTIGATOR

Green Beat + Medical University of Graz

Locations

Institute of Pathophysiology and Immunology

Graz, Styria, Austria

Green Beat

Graz, , Austria

Countries

Austria

Other Identifiers

27-507 ex 14/15

Identifier Type: -

Identifier Source: org_study_id