NCT03526094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1.8 years

First QC Date

May 3, 2018

Last Update Submit

October 6, 2022

Conditions

Healthy

Keywords

flavanolADMEpolyphenolsCocoaBananaepicatechin

Outcome Measures

Primary Outcomes (1)

  • Flavanol metabolites in plasma

    Plasma concentration of flavanol metabolites

    Before to 6 h post test material intake

Secondary Outcomes (1)

  • Flavanol metabolites in urine

    12 h before to 24 h post test material intake

Study Arms (10)

Flavanols-capsules

ACTIVE COMPARATOR

Capsules containing 541 mg cocoa flavanols (75 mg epicatechin) and 315 g of milk (1% fat)

Other: Flavanols-capsules

Flavanol-banana blend

EXPERIMENTAL

Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin)

Other: Flavanol-banana blend

Flavanol-high protein drink

EXPERIMENTAL

Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin)

Other: Flavanol-high protein drink

Flavanol-berry blend

EXPERIMENTAL

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 484 mg cocoa flavanols (68 mg epicatechin)

Other: Flavanol-berry blend

Flavanol-sports drink

EXPERIMENTAL

Drink prepared by mixing 488 g of a sports drink with a CF powder containing 565 mg cocoa flavanols (78 mg epicatechin)

Other: Flavanol-sports drink

Flavanol-peanut butter toast

EXPERIMENTAL

Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin) and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries

Other: Flavanol-peanut butter toast

Flavanol-oats

EXPERIMENTAL

Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 653 mg cocoa flavanols (85 mg epicatechin)

Other: Flavanol-oats

Flavanol-yogurt

EXPERIMENTAL

Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 484 mg cocoa flavanols (68 mg epicatechin)

Other: Flavanol-yogurt

II- Flavanol drink

ACTIVE COMPARATOR

Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 638 mg cocoa flavanols (88 mg epicatechin)

Other: II- Flavanol drink

II- Flavanol drink + banana blend

EXPERIMENTAL

Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 638 mg cocoa flavanols (88 mg epicatechin) Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas

Other: II- Flavanol drink + banana blend

Interventions

Flavanols-capsulesOTHER

Capsules containing 456 mg cocoa flavanols and 315 g of milk (1% fat)

Flavanols-capsules
Flavanol-banana blendOTHER

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

Flavanol-banana blend
Flavanol-high protein drinkOTHER

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

Flavanol-high protein drink
Flavanol-berry blendOTHER

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

Flavanol-berry blend
Flavanol-sports drinkOTHER

Drink prepared by mixing 488 g of a sports drink with a CF powder containing 533 mg cocoa flavanols

Flavanol-sports drink
Flavanol-peanut butter toastOTHER

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

Flavanol-peanut butter toast
Flavanol-oatsOTHER

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

Flavanol-oats
Flavanol-yogurtOTHER

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

Flavanol-yogurt
II- Flavanol drinkOTHER

Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 626 mg cocoa flavanols

II- Flavanol drink
II- Flavanol drink + banana blendOTHER

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

II- Flavanol drink + banana blend

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ragle Human Nutrition Research Center, Department of Nutrition at UC Davis

Davis, California, 95616, United States

Location

UC Davis

Davis, California, 95616, United States

Location

Related Publications (5)

  • Schroeter H, Heiss C, Spencer JP, Keen CL, Lupton JR, Schmitz HH. Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs. Mol Aspects Med. 2010 Dec;31(6):546-57. doi: 10.1016/j.mam.2010.09.008. Epub 2010 Sep 18.

    PMID: 20854838BACKGROUND

  • Ottaviani JI, Momma TY, Kuhnle GK, Keen CL, Schroeter H. Structurally related (-)-epicatechin metabolites in humans: assessment using de novo chemically synthesized authentic standards. Free Radic Biol Med. 2012 Apr 15;52(8):1403-12. doi: 10.1016/j.freeradbiomed.2011.12.010. Epub 2011 Dec 23.

    PMID: 22240152BACKGROUND

  • Koster H, Halsema I, Scholtens E, Knippers M, Mulder GJ. Dose-dependent shifts in the sulfation and glucuronidation of phenolic compounds in the rat in vivo and in isolated hepatocytes. The role of saturation of phenolsulfotransferase. Biochem Pharmacol. 1981 Sep 15;30(18):2569-75. doi: 10.1016/0006-2952(81)90584-0. No abstract available.

    PMID: 6946775BACKGROUND

  • McCullough ML, Chevaux K, Jackson L, Preston M, Martinez G, Schmitz HH, Coletti C, Campos H, Hollenberg NK. Hypertension, the Kuna, and the epidemiology of flavanols. J Cardiovasc Pharmacol. 2006;47 Suppl 2:S103-9; discussion 119-21. doi: 10.1097/00005344-200606001-00003.

    PMID: 16794446BACKGROUND

  • Heiss C, Kleinbongard P, Dejam A, Perre S, Schroeter H, Sies H, Kelm M. Acute consumption of flavanol-rich cocoa and the reversal of endothelial dysfunction in smokers. J Am Coll Cardiol. 2005 Oct 4;46(7):1276-83. doi: 10.1016/j.jacc.2005.06.055.

    PMID: 16198843BACKGROUND

Study Officials

  • Carl L Keen, PhD

    UC Davis

    PRINCIPAL INVESTIGATOR

  • Javier I Ottaviani, PhD

    Mars, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator processing samples and performing statistical analyses
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Cross-over dietary intervention study in healthy young adult males
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

May 5, 2016

Primary Completion

February 9, 2018

Study Completion

February 9, 2018

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Only researchers listed in the protocol and approved by the IRB will have access to IPD.

Locations

US(2)