Hypertension, Hyperlipidemia with LDL-C more than 100 mg/dL Coffee Arabica pulp extract, Coffee pulp, Coffogenic drink, Novel food, Lowering blood pressure, Hypertension, High blood pressure, Hyperlipidemia
Conditions
Interventions
Coffogenic Drink is a coffee arabica pulp extract on lowering blood pressure in hypertensive patients with hyperlipidemia. It consists of sugar 7 grams, calcium not less than 9.99 milligrams, iron not
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
CPE,Placebo
Sponsors
Program Management Unit for Competitiveness (PMUC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male or Female, age is more than or equal to 18 years. 2.Hypertension treated with is more than or equal to 1 anti-hypertensive drug(s) 3.Hyperlipidemia with LDL-C > 100 mg/dL after receiving statin therapy 4.10-year Thai ASCVD risk estimation is more than or equal to 7.5% 5.Stable medications is more than or equal to 1 month(s) 6.If female, the subject is either post-menopausal or surgically sterilized, or has a negative urine kit pregnancy test within 7 plus and minus3 days prior to enrollment and will use adequate contraception during the entre study. 7.Subject can join the entire study (6 months) 8.The subject has provided written informed consent prior to enrollment.
Exclusion criteria
Exclusion criteria: 1.Uncontrolled blood pressure (is more than or equal to 160/110 mmHg) or secondary hypertension. 2.LDL-C > 190 mg/dL or familial hypercholesterolemia 3.Diabetes mellitus (any type and any HbA1c level). 4.Cardiovascular disease (clinical or radiographic diagnosis) or atrial fibrillation 5.Thyroid disorder 6.Active infection or current antibiotic use 7.Concurrent use of antiplatelet(s) or anticoagulant . 8. Thrombocytopenia (< 90,000 per MicroLiter) or anemia (hemogloblin < 10 g/dL) or high bleeding risk. 9.Creatinine clearance < 30 mL/min or requiring renal replacement therapy (hemodialysis or peritoneal dialysis). 10.Pregnancy (section UPT) or lactation. 11.Concomittent liver disease, or alanine amiotransferase (ALT) > 3 times of upper normal limit, or alcohol consumption > 3 days per week and > 2 standard drink per day in male and > 1 standard drink per day in female. 12.Short life expectancy (< 1 year) or active cancer 13.History of poor compliance to treatment. 14.Allergy to coffee or study product. 15.Lack of ability or willingness to give informed consent. 16.Not appropriate for this study for any other reasons based on investigator viewpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure 1-month, 3-month, 4-month, 6-month Automatic arm blood pressure monitor | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardio-Ankle vascular index 1-month, 3-month, 4-month, 6-month Dedicated Cardio-Ankle vascular index measuring machine,Flow-mediated dilatation (FMD) 1-month, 3-month, 4-month, 6-month Brachial artery ultrasound,Blood lipid levels 1-month, 3-month, 4-month, 6-month LDL-C ,Glycemic control 1-month, 3-month, 4-month, 6-month Fasting plasma,glucose,FBS, insulin, HbA1c, TG, TC, LDL-C, HDL-C, hs-CRP, CBC, BUN, Cr, Na, K, Cl, CO2, Ca, P, Mg, LFT,Liver and kidney function 1-month, 3-month, 4-month, 6-month Blood test | — |
Countries
Thailand
Contacts
Public ContactKrit Leemasawat
Faculty of medicine, Chiang Mai University
Outcome results
None listed