Intervention study on regular intake of a flavanol-rich cocoa powder on blood pressure, glucose and fat metabolism in type-2 diabetics with stable metabolic control

Not Applicable

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00011007
• Lead Sponsor: Hochschule Niederrhein, Fachbereich Oecotrophologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-24
• Study Completion: 2017-04-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Type 2 diabetes mellitus with dietetic or pharmacological treatment, duration of diabetes (after diagnosis) at least 1 year, stable metabolic control (HbA1c between 6.5 – 7.5% with consideration of individual therapeutic aims), essential hypertension, arterial hypertension (clinical blood pressure at least 140 mm Hg systolic and/or at least 90 mm Hg diastolic; alternatively 24-h-blood pressure of at least 130 mm Hg systolic and/or at least 80 mm Hg diastolic, non-smoker for at least 3 months, written informed consent

Exclusion Criteria

Insulin therapy, known gastrointestinal diseases accompanied by diarrhea or malabsorption, history of cardiovascular diseases (myocardial infarction, stroke), cardiac pacemaker and other implanted automatically electronic tools, known or planned pregnancy, large consumption of chocolate (> 100 g/day), red wine (> 1 glass/day), cocoa drink, green and black tea (> 1 cup/day), regular supplementation of vitamin preparations, intake of flavanol-rich supplements

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure (systolic);<br>determination before and after 3-months of intervention;<br>blood pressure will be determined oscillometrically at the upper arm in seating position after 5 min of rest according to the recommendations of the European Society of Hypertension and the European Society of Cardiology

Secondary Outcome Measures

Name	Time	Method
Parameters on glucose and lipid metabolism (determined after an overnight fast):<br>glucose, insulin, HOMA-IR, HbA1c, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides<br>