Healthy elderly Dimocarpus longan, bone, lipids, blood glucose, aged
Conditions
Interventions
The study products to be used include the investigational product i.e., Longan extract with Indian gooseberry (Phyllanthus emblica L.),The placebo does not contain Longan extract or Indian gooseberry
instead, it includes coloring and flavoring agents to mimic the appearance, color, odor, and flavor of the investigational product.
Experimental Dietary Supplement,Placebo Comparator No treatment
Longan extract beverage product,Placebo
Sponsors
Phankhum Interfood Co.
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 55 to 75 years at the time of screening; 2. Has a body mass index within the range of 18.5 to 24.9 kg/m2 3. Has blood biochemical laboratory tests as follows: FPG level less than 126 mg/dL; HbA1c level less than 6.5%; Triglyceride level less than 200 mg/dL; LDL level less than 190 mg/dL; and HDL level more than 40 mg/dL 4. Has general good health based on medical history, physical examination, and basic laboratory tests (including CBC, liver function test, BUN, Cr, serum electrolytes, and uric acid); and 5. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Has a history of hypersensitivity to the investigational product, longan, or any ingredient in the investigational product 2.Has a problem with alcoholism, substance abuse, or heavy smoking 3.Has an underlying disease i.e., liver or renal impairment, pulmonary disease, cardiovascular disease, diabetes, and bone metabolism disorders, including osteoporosis, which could have a substantial impact on the trial's result 4.Consumes dietary supplements or other products that affect bone changes within 30 days prior to the screening visit; and 5.Participates in another clinical trial concurrently or within 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone turnover markers Wk 0, 12 Laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profiles Wk 0, 12 Laboratory test,Blood glucose Wk 0, 4, 12 Laboratory test,Health-related quality of life Wk 0, 4, 12 EQ-5D-5L scores,Satisfaction Wk 4, 12 Questionnaire,Adverse events Wk 2, 4, 6, 8, 10, 12 Self reports,Safety (blood biochemical lab tests) Wk 0, 12 Laboratory test: CBC, liver function test, BUN, Cr, electrolytes, and uric acid | — |
Countries
Thailand
Contacts
Public ContactMingkwan Na Takuathung
Faculty of Medicine, Chaing Mai University
Outcome results
None listed