R03.0 R73 I10.9
Conditions
Interventions
Group 1: n=10
Verum + WHO recommendations: This arm gets 2x200 mg polyphenol-rich cocoa extract over 8 weeks and is instructed to follow the WHO recommendations for movement.
After 8 weeks of interven
Sponsors
Deutsche Sporthochschule Köln
Eligibility
Sex/Gender
Female
Age
50 Years to 67 Years
Inclusion criteria
Inclusion criteria: at least 12 months since last menstruation, oestradiol 17/ß in blood 23 U/L, LH > 7.9 IU/L; prehypertension or hypertension I° (systolic 120-159 mmHg, diastolic 80-99 mmHg), prediabetes (100 mg/dl < fasting glucose <126 mg/dl or 5. 7 % < HbA1c <6.5%), smartphone, signed declaration of consent, possibility of visiting the German Sport University to collect the watches and for the examinations
Exclusion criteria
Exclusion criteria: Simultaneous participation in another intervention study, severe underlying diseases, e.g. manifest diabetes mellitus, impaired glucose tolerance, heart failure (stage III or IV), alcohol consumption >14 units/week, intensive sporting activity >10h/week, nicotine consumption, weight changes ± 10% of body weight within the last 6 months, medication intake: - Blood pressure altering medication, - Clopidogrel (due to increase in bioavailability through cocoa flavanols) - Antidiabetics or insulin - Hormone replacement therapy (HRT) - Min. 3-week wash-out of polyphenol-rich supplements (e.g. green tea, berries, grapes (seeds), grapefruit, ...), omega-3 products and antioxidants (e.g. coenzyme Q, ...) Vegan diet, inability to carry out the exercise recommendations of the WHO, cognitive disorders that could impair participation, essential tremor or other diseases associated with tremor (e.g. Parkinson's disease), contraindications for bioimpedance analysis: implanted pacemaker or defibrillator, brain pacemaker, active prostheses, etc., finger or hand deformities or missing upper extremity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the RHI (reactive hyperemia index), which is determined at T1 (initial examination at the start of the study), after 8 weeks at T2 (half of the subjects have undergone the intervention at this point, the other half served as a waiting control group), and after another 8 weeks at T3 (end of the study). It is measured by measuring PAT (peripheral arterial tonometry) using EndoPAT device from Itamar Medical. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary endpoints are measured once at T1, after 8 weeks at T2, and after another 8 weeks at T3. Pulse wave velocity and augmentation index, measured using the mobil-o-graph from IEM, Blood pressure, measured using a standard blood pressure monitor Body composition, measured using bioimpedance analysis, device from seca SCORE2, calculated parameter Blood lipid levels, fasting glucose, inflammation parameters (hsCRP, TNF-alpha, IL-6), endothelial biomarkers (sICAM, sVCAM, oxLDL, sE-selectin, sP-selectin, endoglin, nitrite, RxNO), oxidative stress, total antioxidant capacity, erythrocyte rheology, complete blood count, cognitive biomarkers in PBMC (in collaboration with the University of Giessen), determined by our in-house laboratory cognitive abilities (trail-making test, verbal learning and memory test), hand grip strength, measured using a dynamometer 6-minute walk test, 60-second sit-to-stand test, menopausal symptoms using the Menopausal Rating Scale, quality of life using SF-12 (Short Form-12) | — |
Countries
Germany
Contacts
Public ContactThomas Schmidt
Deutsche Sporthochschule Köln
Outcome results
None listed