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Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes

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ClinicalTrials.gov Identifier: NCT03526094
Recruitment Status : Completed
First Posted : May 16, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Mars, Inc.
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Dietary intervention study in healthy adult males to evaluate concentration of flavanol metabolites in plasma and urine after single acute intakes of flavanols from different fruit-based drinks.

Condition or disease Intervention/treatment Phase
Healthy Other: Flavanols-capsules Other: Flavanol-banana blend Other: Flavanol-high protein drink Other: Flavanol-berry blend Other: Flavanol-sports drink Other: Flavanol-peanut butter toast Other: Flavanol-oats Other: Flavanol-yogurt Other: II- Flavanol drink Other: II- Flavanol drink + banana blend Not Applicable

Detailed Description:

Flavonoids, including the sub groups of Flavanols (F) are plant-derived compounds commonly present in the human diet. Examples of F-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of F-containing foods and beverages has been associated with improvements in cardiovascular health. In this context, there exists a great interest in describing the absorption, metabolism and excretion of F in humans, as it is thought that F-derived metabolites present in circulation are the mediators of F-beneficial effects in humans. Recently, the investigators described a series of F-derived metabolites in circulation that are present after the consumption of a single acute intake amount of F in humans as well as F-metabolites derived from the metabolic activity of the gut microbiome. A key question, however, is if the metabolites we observed after a single acute feeding are the same as those that occur in individuals who consume F-rich diets on a regular basis. Studies investigating the metabolism of numerous other xenobiotics have shown that the profile of metabolites can greatly vary over time, as well as with the amount of the xenobiotic ingested. In this context, the investigators submit it is important to assess whether or not there are food matrix-dependent effects on the levels and profile of F-derived metabolites in humans. The investigators suggest the information that will be obtained from the outlined work will be particularly timely given ongoing discussion concerning the possible generation of dietary recommendations for F-rich foods and increasing interest in the putative health effects of F intake in humans.

This study consisted of two parts. One part investigated flavanols absorption and metabolism from different fruit-based drinks and other food matrixes. The second part investigated flavanol absorption and metabolism after the intake of a flavanol drink alone and simultaneously consumed with a banana-based drink.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over dietary intervention study in healthy young adult males
Masking: Single (Investigator)
Masking Description: Investigator processing samples and performing statistical analyses
Primary Purpose: Basic Science
Official Title: Flavanol Absorption, Metabolism and Excretion From Fruit-based Drinks and Other Food Matrixes
Actual Study Start Date : May 5, 2016
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Arm Intervention/treatment
Active Comparator: Flavanols-capsules
Capsules containing 456 mg cocoa flavanols and 315 g of milk (1% fat)
Other: Flavanols-capsules
Capsules containing 456 mg cocoa flavanols and 315 g of milk (1% fat)

Experimental: Flavanol-banana blend
Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 626 mg cocoa flavanols
Other: Flavanol-banana blend
Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 626 mg cocoa flavanols

Experimental: Flavanol-high protein drink
Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 533 mg cocoa flavanols
Other: Flavanol-high protein drink
Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 533 mg cocoa flavanols

Experimental: Flavanol-berry blend
Fruit blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 561 mg cocoa flavanols
Other: Flavanol-berry blend
Flavanol-berry blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 561 mg cocoa flavanols

Experimental: Flavanol-sports drink
Drink prepared by mixing 488 g of a sports drink with a CF powder containing 533 mg cocoa flavanols
Other: Flavanol-sports drink
Drink prepared by mixing 488 g of a sports drink with a CF powder containing 533 mg cocoa flavanols

Experimental: Flavanol-peanut butter toast
Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 602 mg cocoa flavanols and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries
Other: Flavanol-peanut butter toast
Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 602 mg cocoa flavanols and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries

Experimental: Flavanol-oats
Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 602 mg cocoa flavanols
Other: Flavanol-oats
Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 602 mg cocoa flavanols

Experimental: Flavanol-yogurt
Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 561 mg cocoa flavanols
Other: Flavanol-yogurt
Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 561 mg cocoa flavanols

Active Comparator: II- Flavanol drink
Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 626 mg cocoa flavanols
Other: II- Flavanol drink
Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 626 mg cocoa flavanols

Experimental: II- Flavanol drink + banana blend
Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 626 mg cocoa flavanols Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas
Other: II- Flavanol drink + banana blend
Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 626 mg cocoa flavanols Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas




Primary Outcome Measures :
  1. Flavanol metabolites in plasma [ Time Frame: Before to 6 h post test material intake ]
    Plasma concentration of flavanol metabolites


Secondary Outcome Measures :
  1. Flavanol metabolites in urine [ Time Frame: 12 h before to 24 h post test material intake ]
    Amount of flavanols metabolites excreted in urine



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No prescription medications
  • BMI 18.5 - 29.9 kg/m2
  • Weight ≥ 110 pounds
  • previously consumed cocoa, peanut, parsley, celery and chamomile products with no adverse reactions

Exclusion Criteria:

  • Adults unable to consent
  • Prisoners
  • Non-English speaking*
  • BMI ≥ 30 kg/m2
  • Performing vigorous physical activity (i.e. more than 6 MET; metabolic equivalence of task as defined by CDC and ACSM guidelines (http://www.cdc.gov/physicalactivity/everyone/glossary/index.html#vig-intensity; and http://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA_Intensity_table_2_1.pdf ) for more than 3 days a week.
  • Dietary allergies including those to nuts, cocoa and chocolate products, parsley, celery and chamomile.
  • Active avoidance of coffee and caffeinated soft drinks
  • Under current medical supervision
  • A history of cardiovascular disease, stroke, renal, hepatic, or thyroid disease
  • History of clinically significant depression, anxiety or other psychiatric condition
  • History of Raynaud's disease
  • History of difficult blood draws
  • Indications of substance or alcohol abuse within the last 3 years
  • Current use of herbal, plant or botanical supplements (multi-vitamin/mineral supplements are allowed)
  • Blood Pressure > 140/90 mm Hg
  • GI tract disorders, previous GI surgery (except appendectomy)
  • Self-reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas)
  • Diarrhea within the last 3 months, or antibiotic intake within the last 3 months
  • Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or individuals following diets with significant deviations from the average diet
  • Metabolic panel and cholesterol results or complete blood counts that are outside of the normal reference range and are considered clinically relevant by the study physician
  • Cold, flu, or upper respiratory condition at screening
  • Currently participating in a clinical or dietary intervention study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526094


Locations
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United States, California
Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis
Davis, California, United States, 95616
UC Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Mars, Inc.
Investigators
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Principal Investigator: Carl L Keen, PhD UC Davis
Study Director: Javier I Ottaviani, PhD Mars, Inc.

Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03526094     History of Changes
Other Study ID Numbers: 429275-D
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only researchers listed in the protocol and approved by the IRB will have access to IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
flavanol
ADME
polyphenols
Cocoa
Banana
epicatechin