type 2 diabetes mellitus Effect of coffee pulp extract powder on glycemic control in type 2 diabetes mellitus (CPE 02)
Conditions
Interventions
Volunteers were given either a coffee berry extract powder (Coffogenic instant ready mix) or a placebo, which had the same appearance and characteristics as the CPE product.,Volunteers consumed CPE pr
Diagnostic,Diagnostic
DM,DM+CPE
Sponsors
Program Management Unit for Competitiveness (PMUC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with type 2 diabetes for more than 1 year 2. Over 18 years old 3. Received stable doses of diabetes and lipid-lowering drugs for more than 3 months 4. Accumulated sugar level 6.5-10% 5. If female volunteers, they must be postmenopausal or sterilized or be a reproductive age woman who is not pregnant from a urine test and will do Contraception for 25 weeks of study participation 6. Able to participate in the project for 6 months 7. Signed the consent form to participate in the research project
Exclusion criteria
Exclusion criteria: 1. Diabetic who receives insulin injection or GLP-1RA 2. Severe liver or kidney disease (GOT/GPT > 3 times the maximum value or total bilirubin/direct bilirubin more than 2.0/1.0 mg/dl or eGFR < 45) 3. Uncontrolled thyroid disease 4. History of organ transplant 5. Immunocompromised, immunocompromised, cancer, and taking immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, and chemotherapeutic agents 6. Pregnant or breastfeeding 7. Taking drugs that may increase blood sugar levels within 4 weeks before joining the study, such as corticosteroids, immunosuppressive agents 8. Taking drugs that may affect blood lipid levels, such as oral contraceptive pills, high dose diuretics or beta-blockers, antiretroviral protease inhibitors, tegretol, and anabolic steroids Except for those who have been taking these drugs continuously at a stable dose for at least 8 weeks before joining the study. 9. Using weight loss drugs within 3 months before joining the research project or having a weight change of more than 5% within the past 3 months. 10. People with a history of coffee or caffeine allergy. 11. Drinking alcohol more than 3 times a week, drinking beer > 360 ml, liquor > 45 ml, wine > 150 ml in women or drinking beer > 720 ml, liquor > 90 ml, wine > 300 ml in men at a time. 12. Patients with cancer within 5 years or heart failure stage 3-4 who are undergoing treatment. 13. Patients with uncontrolled diabetes HbA1C > 10% or FBS > 240 mg/dL. 14. Having gastrointestinal symptoms, including nausea, vomiting, loss of appetite, early satiety, diarrhea, or chronic constipation. 15. People who do not sign the consent form to join the research project. 16. Patients with a history of cerebrovascular disease. Acute coronary artery disease in the past 1 year 17. Patients who participated in other research studies that used drugs or chemicals for consumption in the past 3 months 18. Patients who the researcher has the discretion to not be suitable to participate in the research project due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of coffee pulp extract powder (Coffogenic Instant Ready Mix) to reduce blood sugar levels in patients with type 2 diabetes week 4, week 12 and week 24 randomized study between a Coffogenic Instant Ready Mix and Placebo The packaging was labeled as A and B both the researchers and volunteers do not know which is A or B. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of coffee pulp extract powder on insulin resistance, blood lipid level, abdominal fat, waist circumference, weight and body mass index and side effects in patients with type 2 diabetes week 4, week 12 and week 24 randomized study between a Coffogenic Instant Ready Mix and Placebo The packaging was labeled as A and B both the researchers and volunteers do not know which is A or B. | — |
Countries
Thailand
Contacts
Public ContactChutima Vaddhanaphuti
Faculty of medicine, Chiang Mai University
Outcome results
None listed