Clinical trial NCT02587468: Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins
Official title: Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins of a Commercially Available, Encapsulated Nutraceutical (Juice Plus+®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: phenolics
absorption
fruit & vegetable concentrate
Bioavailability of phenolic compounds
Lead sponsor: Green Beat
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2015-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Absorption of ß-carotene after 8 weeks of supplementation, measured via HPLC, evaluated by paired t-test, and assessed via SPSS 19.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Institute of Pathophysiology and Immunology
state: Styria
city: Graz
country: Austria
facility: Green Beat
Study officials:
affiliation: Green Beat + Medical University of Graz
name: Manfred Lamprecht, PhD
role: PRINCIPAL_INVESTIGATOR
References: