None listed
Conditions
Interventions
Oral intake of synbiotic powder (2 sticks in a day
4 weeks).
Oral intake of the placebo powder (2 sticks in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals aged 65 or older but under 75 at the time of obtaining the informed consent document for trial participation.
Exclusion criteria
Exclusion criteria: 1) Individuals currently suffering from any chronic disease and undergoing drug therapy. 2) Individuals regularly taking medications that affect the intestinal environment (such as antibiotics, intestinal regulators, laxatives, or purgatives). 3) Individuals regularly consuming foods or supplements containing bacteria such as lactic acid bacteria or bifidobacteria, oligosaccharides, or other ingredients that affect the intestinal environment or intestinal function. 4) Individuals with severe anemia. 5) Individuals with a BMI of 30 kg/m2 or higher. 6) Individuals whose average weekly alcohol consumption exceeds 40 g/day for men and 20 g/day for women, based on pure alcohol content. 7) Individuals with a smoking habit. 8) Individuals participating in other human clinical trials. 9) Individuals receiving treatment for liver, kidney, heart, lung, digestive, blood, nervous system, endocrine system, or metabolic disorders, or individuals with a history of severe conditions in these areas. 10) Individuals with a history of drug allergies or severe food allergies. 11) Individuals who underwent blood collection of 400 mL or more within 12 weeks prior to the start of intake. 12) Individuals deemed unsuitable as subjects by the study physician based on results from subject background, physical examination findings, medical history and physical examination, physical examination, and laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota | — |
Secondary
| Measure | Time frame |
|---|---|
| <Secondary Evaluation Items> 1) Organic acids in stool 2) Stool pH 3) Putrefactive products in stool 4) Defecation status (fecal odor, stool consistency, frequency, stool volume) 5) Mood Profile Test 6) High-Sensitivity CRP 7) Sleep Status 8) NAD+ 9) Body Composition 10) Skin Condition <Safety> Adverse events and side effects | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed