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Completed

NCT Number: NCT02587468

Bioavailability and Absorption Kinetics of Phenolic Compounds and Specific Vitamins

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).

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Pathophysiology and Immunology, Graz, Styria, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Juice Plus+(R)

Dietary Supplement

before-after comparison of plasma phenolics

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.

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Green Beat

Other

Collaborators

  • Medical University of Graz

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2015
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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