Subjects with hypercholesterolemia Wolffia globosa, gut microbiome, immune function, lipid profile, hypercholesterolemia
Conditions
Interventions
A 10-gram powder sachet containing maltodextrin, coloring, and fruit flavor,A 10-gram powder sachet (containing 5 grams of Wolffia per sachet)
Placebo group,Wolffia group
Sponsors
Center of Excellence for Microbiota Innovation, Faculty of Agro-Industry, Kasetsart University
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Male and female volunteers aged 20-50 years 2. Diagnosed with elevated low-density lipoprotein cholesterol (LDL-C) levels, with LDL-C between 130-190 mg/dL 3. If taking medications that affect LDL-C levels, there must be no medication adjustments within 3 months prior to study enrollment 4. Body mass index (BMI) between 23.0-29.9 kg/m2 5. Normal renal function, with blood urea nitrogen (BUN) and creatinine levels ranging from 8-24 mg/dL and 0.84-1.21 mg/dL, respectively 6. Normal liver function, with aspartate transaminase (AST) and alanine transaminase (ALT) levels ranging from 8-48 U/L and 7-55 U/L, respectively 7. Able to comply with all study procedures and provide informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. History of regular smoking or alcohol consumption 2. Use of antibiotics within 3 months prior to enrollment or during the study 3. Changes in the type or dose of lipid-lowering medications within 3 months prior to enrollment or during the study 4. Use of dietary supplements containing probiotics, prebiotics, or synbiotics within 1 month prior to enrollment or during the study 5. Inability to consume dietary fiber, as evaluated through medical history taking and review of medical records. Participants will be questioned regarding underlying conditions or states that may limit fiber intake (e.g., intestinal obstruction, inflammatory bowel disease, or medical conditions where a physician advises fiber restriction), as well as any past history of consuming fiber-rich foods or fiber supplements (e.g., symptoms of bloating, abdominal fullness, abdominal pain, diarrhea, or other adverse reactions). If a participant is found to have limitations or intolerance to dietary fiber, the investigator will exclude them according to the criteria 6. Gastrointestinal or bowel diseases that may impair digestion or absorption, including inflammatory bowel disease (IBD) such as Crohn's disease and ulcerative colitis, short bowel syndrome, malabsorption syndrome, celiac disease, intestinal obstruction, and gastrointestinal conditions where a physician recommends fiber restriction or where dietary fiber intake is limited. 7. History of allergy to Wolffia (watermeal) and/or products containing Wolffia as an ingredient. 8. History of cerebrovascular disease, heart disease, or diabetes mellitus. 9. Pregnant or lactating women. 10. History of gout or diagnosed with gout by a physician. 11. Hyperuricemia currently under treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C After 12 weeks of intervention Assay kits, chemical reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiome After 12 weeks of intervention, and 2 week of washout period 16s rRNA gene sequencing,Fecal short-chain fatty acids After 12 weeks of intervention, and 2 week of washout period Gas Chromatography-Flame Ionization Detector (GC-FID),Caloric intake After 12 weeks of intervention, and 2 week of washout period 3-day food record,Total choplesterol, HDL-C, triglyceride After 12 weeks of intervention Assay kits, chemical reactions,Stool characteristic data After 12 weeks of intervention, and 2 week of washout period Questionnaire,Fasting blood glucose, Serum CRP After 12 weeks of intervention Assay kits, chemical reactions,BUN, Creatinine, AST, ALT before and after 12 weeks of intervention Assay kits, chemical reactions | — |
Countries
Thailand
Contacts
Public ContactSanit Wichansawakun
Department of Internal Medicine, Faculty of Medicine, Thammasat University
Outcome results
None listed