NCT04298970

Brief Summary

Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 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

March 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 4, 2023

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

March 3, 2020

Last Update Submit

December 1, 2023

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • iAUC

    The blood glucose incremental area under curve, OGTT

    Throughout the study (up to 1 year)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Consuming a product containing 35-40 gram of freeze dried kale a day.

Dietary Supplement: Intervention

Placebo

PLACEBO COMPARATOR

Consuming a placebo product.

Dietary Supplement: Placebo

Interventions

InterventionDIETARY_SUPPLEMENT

Freeze-dried Brassica oleracea var. acephala

Intervention
PlaceboDIETARY_SUPPLEMENT

Placebo product

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes, dietary treatment and/or with oral anti-diabetics
  • Diabetes debut \> 30 year
  • Plasma fasting blood glucose \> 4mM and \< 12 mM
  • HbA1c \> 43 and ≤ 108 mmol/mol
  • BMI between 23-40 kg/m2
  • Fasting triglyceride \> 1.7 mmol/L and HDL-cholesterol, men: \< 1.03 mmol/L and women: 1.29 mmol/L.

You may not qualify if:

  • Participating or have been participating in other clinical trials within the last 2 months.
  • In treatment with insulin, systemic glucocorticoids, glitazones or GLP-1 analogs.
  • Cardiovascular-, physiological-, neurological-, and/or kidney diseases.
  • Alcohol- or pill abuse.
  • Acute diseases.
  • Blood pressure ≥ 160/100
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus C, 8000, Denmark

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate. Prof, Phd, Diabetes and hormone diseases

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 6, 2020

Study Start

March 3, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 4, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)