The short-term safety of daily small protein sericin intake in healthy volunteers is investigated including blood lipid levels, anti-oxidative capacity, inflammatory marker and gut microbiota. sericin-derived oliopeptides (SDO), yellow silk cocoon, healthy volunteer
Conditions
Interventions
To assess the safety of sericin-derived oligopeptides (SDO) capsule extracted from yellow silk cocoons when given at doses of 0.9 g/day in healthy volunteers for 8 weeks.,To assess the safety of seric
Active Comparator Dietary Supplement,Active Comparator Dietary Supplement,Placebo Comparator No treatment
0.9 g/day,1.8 g/day,1.8 g/day maltodextrin
Sponsors
The Agricultural Research Development Agency (Public Organization), ARDA
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Male or female volunteers aged between 20 and 45. (2) Body Mass Index (BMI) 18-25kg/m2 (3) Healthy status through medical history checks, drug abuse, physical examinations and vital signs. (4) Clinical chemistry (BUN, creatinine, AST (SGPT), ALT (SGPT), Alkaline phosphatase, albumin, total protein, total bilirubin, fasting glucose, hematology (CBC: RBC, WBC, hemoglobin, hematocrit, platelets) and urinalysis (5) Hepatitis B and C tested negative (HBs antigen and anti-HCV). (6) The negative test result of pregnancy test and no breastfeeding for female volunteers. (7) Able to write, read, and communicate in Thai. (8) Willing to participate in the research and signing a consent form to participate in the research plan.
Exclusion criteria
Exclusion criteria: (1) Any allergic history to animal or plant proteins such as sericin protein, silk protein, milk protein or soybean protein, etc. (2) Have allergic diseases, diabetes, hyperlipidemia, cardiovascular diseases, liver diseases, kidney diseases, digestive system diseases, blood diseases and/or other diseases that may affect the research results. (3) Have a history of frequent alcoholic beverages drinking such as drinking beer or liqueur more than once a week, or of drug addiction. (4) Have a history of smoking or recent smoking (stop smoking less than 30 days before the study) (5) Drink coffee and/or caffeinated drinks more than twice a day. (6) Receive any drugs within 14 days before the start of study, and intend to continue to use them during the whole study period. (7) Use or take dietary supplements, vitamins or minerals, herbs and/or contraceptives within 14 days before the start of study, and intend to continue using them during the whole study period. (8) Have participated in other clinical studies within 30 days before participating in the study. (9) Have donated blood within 90 days before participating in the study. (10) Women who plan to get pregnant during the study and after one month of the end of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety analysis-lab parameters and physical examination at 0, 4 and 8 weeks after the start of the intervention BUN, creatinine, SGOT, SGPT, alkaline phosphatase (ALP), albumin, total protein, total bilirubin, complete blood count (CBC), urinalysis, fasting blood glucose, physical examination (BP, HR) ,Safety analysis -adverse events Throughout the entire study period (self record), and at 4 and 8 weeks after the start of the intervention by investigator interview Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid profile at 0, 4 and 8 weeks after the start of the intervention Plasma total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides,Inflammatory markers at 0, 4 and 8 weeks after the start of the intervention Plasma IL-6, TNF-alpha, IFN-gramma, IL1-bata, IL-10,Oxidative stress at 0, 4, and 8 weeks after the start of the intervention Plasma malonaldehyde (MDA) ,Antioxidative capacity at 0, 4, and 8 weeks after the start of the intervention Plasma total antioxidant capacity (TAC) and superoxide dismutase activity (SOD),Gut microbiota at before (week 0) and the end of the intervention (week 8) Relative operational taxonomic units (OTU) by 16S rRNA metagenome sequencing | — |
Countries
Thailand
Contacts
Public ContactWatchara Pichitsiri
Faculty of Medicine, Naresuan University
Outcome results
None listed