Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298970
• Other study ID #: AU/AUH
• Status: Completed
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Dietary Supplement:
• Intervention
Freeze-dried Brassica oleracea var. acephala
• Placebo
Placebo product

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Future Food Innovation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iAUC	The blood glucose incremental area under curve, OGTT	Throughout the study (up to 1 year)