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

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Intervention

• Registration Number: NCT04298970
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Consuming a placebo product.
Intervention	Intervention	Consuming a product containing 35-40 gram of freeze dried kale a day.

Primary Outcome Measures

Name	Time	Method
iAUC	Throughout the study (up to 1 year)	The blood glucose incremental area under curve, OGTT

Trial Locations

Locations (1)

Aarhus University; 🇩🇰 Aarhus C, Denmark