NCT04647175

Brief Summary

In a triple-crossover study, the effect aronia consumption on type 2 diabetes will be examined. 48 type 2 diabetes patients need to complete the trial. Each patient will receive two daily doses of both fermented aronia, aronia, or placebo for eight weeks each. There will be 3 weeks wash-out periods between the intervention periods. Before and after the intervention periods, various measurements will be performed to assess the effects of aronia, fermented aronia, and placebo on type 2 diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

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
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

November 20, 2020

Last Update Submit

March 11, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

Aronia

Outcome Measures

Primary Outcomes (2)

  • Blood glucose incremental area under the curve (iAUC)

    Measured during the OGTTs

    Throughout the study (up to 1 year)

  • Blood glucose total area under the curve (tAUC)

    Measured during the OGTTs

    Throughout the study (up to 1 year)

Secondary Outcomes (14)

  • Glucose

    Throughout the study (up to 1 year)

  • Insulin

    Throughout the study (up to 1 year)

  • HbA1c

    Throughout the study (up to 1 year)

  • Fructosamin

    Throughout the study (up to 1 year)

  • Lipids

    Throughout the study (up to 1 year)

  • +9 more secondary outcomes

Study Arms (6)

Fermented aronia - aronia - placebo

OTHER

The participants receive each intervention for 8 weeks in the stated order.

Other: Fermented aroniaOther: AroniaOther: Placebo

Fermented aronia - placebo - aronia

OTHER

The participants receive each intervention for 8 weeks in the stated order.

Other: Fermented aroniaOther: AroniaOther: Placebo

Placebo - aronia - fermented aronia

OTHER

The participants receive each intervention for 8 weeks in the stated order.

Other: Fermented aroniaOther: AroniaOther: Placebo

Placebo - fermented aronia - aronia

OTHER

The participants receive each intervention for 8 weeks in the stated order.

Other: Fermented aroniaOther: AroniaOther: Placebo

Aronia - placebo - fermented aronia

OTHER

The participants receive each intervention for 8 weeks in the stated order.

Other: Fermented aroniaOther: AroniaOther: Placebo

Aronia - fermented aronia - placebo

OTHER

The participants receive each intervention for 8 weeks in the stated order.

Other: Fermented aroniaOther: AroniaOther: Placebo

Interventions

Fermented aroniaOTHER

Given twice daily for 8 weeks

Aronia - fermented aronia - placeboAronia - placebo - fermented aroniaFermented aronia - aronia - placeboFermented aronia - placebo - aroniaPlacebo - aronia - fermented aroniaPlacebo - fermented aronia - aronia
AroniaOTHER

Given twice daily for 8 weeks

Aronia - fermented aronia - placeboAronia - placebo - fermented aroniaFermented aronia - aronia - placeboFermented aronia - placebo - aroniaPlacebo - aronia - fermented aroniaPlacebo - fermented aronia - aronia
PlaceboOTHER

Given twice daily for 8 weeks

Aronia - fermented aronia - placeboAronia - placebo - fermented aroniaFermented aronia - aronia - placeboFermented aronia - placebo - aroniaPlacebo - aronia - fermented aroniaPlacebo - fermented aronia - aronia

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • ≥30 ≤80 years of age
  • Fasting blood glucose ≤12 mmol/liter.
  • HbA1c \> 6,1% og \<10%(\>43 og \< 86 mmol/mol) if patients are in medical diabetes treatment
  • HbA1c \> 6,5% og \<10% (\>48 og \< 86 mmol/mol) if patients are not in medical diabetes treatment

You may not qualify if:

  • Changes in diabetes within the last 3 months.
  • Serious comorbidities, including cardiovascular-, neurological-, psychological- and/or renal diseases.
  • Pregnant or planned pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Danmark, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 30, 2020

Study Start

November 23, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

DK(1)