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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

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 - CocoaProtect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011007
Enrollment
42
Registered
2016-08-24
Start date
2016-09-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E11

Interventions

Group 1: 2.5 g Cocoa powder/day (encapsulated) for 3 months
mean flavanol content according to manufacturer about 208 mg per 2.5 g cocoa powder Group 2: Placebo capsules with microcristalline cellulose

Sponsors

Hochschule Niederrhein, Fachbereich Oecotrophologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Blood pressure (systolic); determination before and after 3-months of intervention; 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

MeasureTime frame
Parameters on glucose and lipid metabolism (determined after an overnight fast): glucose, insulin, HOMA-IR, HbA1c, total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides

Countries

Germany

Contacts

Public ContactLisa Dicks

Diabetes Praxis Rathausallee

Lisa.Dicks@stud.hn.de02151-535251

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026