NCT04645394

Brief Summary

In a quadruple cross-over design, 8 healthy men will receive 3 different formulations of Aronia extract as well as placebo (placebo, aronia, and fermented aronia in 1/6 and 1/1 concentration). The intervention will be given on four separate days at least three days apart. Before consumption, 2 fasting blood samples will be taken. Blood will also be sampled at 60, 120, 240, and 360 minutes post consumption. The blood samples will be analyzed for polyphenolic content with a special focus on anthocyanins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 20, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

March 28, 2022

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 20, 2020

Last Update Submit

March 11, 2022

Conditions

Bioavailability

Keywords

bioavailabilityAronia melanocarpapolyphenolsanthocyaninshealthymenuptake

Outcome Measures

Primary Outcomes (2)

  • area under the curve for anthocyanin blood concentration

    Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption

    -15, 0, 60, 120, 240, 360 minutes

  • incremental area under the curve for anthocyanin blood concentration

    Blood is sampled before (-15, 0) and after (60, 120, 240, 360) consumption

    -15, 0, 60, 120, 240, 360 minutes

Secondary Outcomes (2)

  • Concentration of polyphenols in the blood

    -15, 0, 60, 120, 240, 360 minutes

  • Antioxidant activity in the blood

    -15, 0, 60, 120, 240, 360 minutes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

The participants are receiving 1 dose of each in the stated order.

Dietary Supplement: Aronia melanocarpaDietary Supplement: Fermented Aronia Melanocarpa high doseDietary Supplement: Fermented Aronia Melanocarpa low doseDietary Supplement: Placebo

Fermented aronia high dose

ACTIVE COMPARATOR

The participants are receiving 1 dose of each in the stated order.

Dietary Supplement: Aronia melanocarpaDietary Supplement: Fermented Aronia Melanocarpa high doseDietary Supplement: Fermented Aronia Melanocarpa low doseDietary Supplement: Placebo

Fermented aronia low dose

ACTIVE COMPARATOR

The participants are receiving 1 dose of each in the stated order.

Dietary Supplement: Aronia melanocarpaDietary Supplement: Fermented Aronia Melanocarpa high doseDietary Supplement: Fermented Aronia Melanocarpa low doseDietary Supplement: Placebo

Aronia

ACTIVE COMPARATOR

The participants are receiving 1 dose of each in the stated order.

Dietary Supplement: Aronia melanocarpaDietary Supplement: Fermented Aronia Melanocarpa high doseDietary Supplement: Fermented Aronia Melanocarpa low doseDietary Supplement: Placebo

Interventions

Aronia melanocarpaDIETARY_SUPPLEMENT

Administered once (acute study)

Also known as: Chokeberry
AroniaFermented aronia high doseFermented aronia low dosePlacebo
Fermented Aronia Melanocarpa high doseDIETARY_SUPPLEMENT

Administered once (acute study)

Also known as: Chokeberry
AroniaFermented aronia high doseFermented aronia low dosePlacebo
Fermented Aronia Melanocarpa low doseDIETARY_SUPPLEMENT

Administered once (acute study)

Also known as: Chokeberry
AroniaFermented aronia high doseFermented aronia low dosePlacebo
PlaceboDIETARY_SUPPLEMENT

Administered once (acute study)

AroniaFermented aronia high doseFermented aronia low dosePlacebo

Eligibility Criteria

Age20 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • man between ≥20 ≤75 years of age

You may not qualify if:

  • Daily usage of medicine, alcohol- or substance abuse
  • BMI ≥30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Danmark, 8200, Denmark

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Acute 4-arm crossover intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 27, 2020

Study Start

November 23, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

March 28, 2022

Record last verified: 2020-11

Locations

DK(1)