hyperlipidemia-obese humans Ready-to-drink supplement product derived from Coffea arabica pulp.
Conditions
Interventions
Volunteers consumed coffogenic ready to drink. (CPE),Volunteers were given placebo that has the same appearance as the ready-to-drink coffogenic.
Diagnostic,Diagnostic
Ready-to-drink (CPE),Placebo
Sponsors
Hillkoff Company Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male or female aged 18 years and over 2) Have a body mass index more than or equal to 25 kg/m 3) Have high cholesterol (LDL-C value more than or equal to 130 mg/dl) 4) If receiving lipid-lowering medication, the medication must be taken at a constant dose for at least 8 weeks 5) If female volunteers, they must be menopausal or sterilized or not pregnant from urine test and will use birth control throughout 25 weeks of study participation 6) Participate in the project for the entire 6 months 7) Sign the consent form to participate in the research project 8) Joining other studies within 8 weeks before joining this research project 9) Taking medications that may affect blood lipid levels, such as oral contraceptive pills, high dose diuretics or beta- blockers, antiretroviral protease inhibitors, Tegretol, and anabolic steroids unless these are used continuously 10) Use of weight loss medication within 3 months prior to the study 11) People with a history of coffee or caffeine allergy 12) Triglyceride levels exceeding 400 mg/dL 13) Have been hospitalized for acute illness within 2 months prior to the study 14) Drink alcohol more than 2 times per week 15) Have gastrointestinal symptoms such as nausea, vomiting, anorexia, fast satiety, diarrhea or chronic constipation 16) Not sign the consent form to participate in the study
Exclusion criteria
Exclusion criteria: 1) diabetes 2) Severe liver or kidney disease (GOT/GPT more than 3 times the maximum value or total bilirubin/direct bilirubin more than 2.0/1.0 mg/dL or eGFR lower than 45 mL/min) 3) Uncontrolled thyroid disease 4) History of organ transplant 5) Immunocompromised persons, persons with immune deficiency, cancer, including taking immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, and chemotherapeutic agents 6) Pregnant or breastfeeding women 7) Taking medications that may increase blood sugar levels within 4 weeks before joining the study, such as corticosteroids, immunosuppressive agents 8) Participated in another study within 8 weeks prior to this study. 9) Take medications that may affect blood lipid levels, such as oral contraceptive pills, high dose diuretics or beta- blockers, antiretroviral protease inhibitors, tegretol, and 22 anabolic steroids, unless they have been used continuously at a steady dose for at least 8 weeks prior to study entry. 10) Use of weight loss medication within 3 months prior to the study 11) People with a history of coffee or caffeine allergy 12) Triglyceride levels exceeding 400 mg/dL 13) Have been hospitalized for acute illness within 2 months prior to the study 14) Drink alcohol more than 2 times per week 15) Have gastrointestinal symptoms such as nausea, vomiting, anorexia, fast satiety, diarrhea or chronic constipation 16) Not sign the consent form to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of ready-to-drink supplement product derived from Coffea arabica pulp extract on lipid profiles and hepatic steatosis in hyperlipidemia-obese humans week4, week8, week12, week16, week20, week24 randomized study between coffogenic ready to drink and Placebo The packaging was labeled as A and B Which will provide 35 and 20 kilocalories of energy, with 7 and 5 grams of sugar per bottle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of ready to drink supplement on reducing the amount of fat in liver, visceral fat, insulin resistance, oxidative stress in blood, body weight in hyperlipidemia-obese humans week4, week8, week12, week16, week20, week24 randomized study between coffogenic ready to drink and Placebo The packaging was labeled as A and B Which will provide 35 and 20 kilocalories of energy, with 7 and 5 grams of sugar per bottle. | — |
Countries
Thailand
Contacts
Public ContactChutima Vaddhanaphuti
Faculty of medicine, Chiang Mai University
Outcome results
None listed