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

University of Aarhus

Status: Completed

Conditions: Type2 Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04298970

AU/AUH

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Intervention

Placebo

Placebo Comparator group

Description:

Consuming a placebo product.

Treatment:

Dietary Supplement: Placebo