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OpenTrials
Completed

NCT Number: NCT04298970

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

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.

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Key information

Conditions

Type2 Diabetes

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Dietary Supplement

Freeze-dried Brassica oleracea var. acephala

Placebo

Dietary Supplement

Placebo product

Primary outcomes

  1. iAUC

    Time frame: Throughout the study (up to 1 year)

    The blood glucose incremental area under curve, OGTT

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Future Food Innovation

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2020
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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