Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Juice Plus+(R)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juice Plus+(R)<br>Check of phenolic absorption between baseline and after 8wks of intake before-after comparison | Dietary Supplement: Juice Plus+(R)<br>* before-after comparison of plasma phenolics<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phenolics, absorption, fruit & vegetable concentrate, Bioavailability of phenolic compounds