Muscle Weakness
Conditions
Keywords
gut microbiome, probiotics, muscle strength, intervention
Brief summary
This study aims to investigate the effects of probiotics named GI Biome #7 on the gut microbiome and muscle strength in older adults aged 60 years or older.
Detailed description
This study is a double-blind, randomized controlled trial. A total of 60 healthy adults aged 60 years or older will be recruited, and they will be randomly assigned to the intervention group or the control group. The intervention group will be given GI Biome #7 pills, and the control group will be given the placebo pills for four weeks. The participants will visit the research laboratory four times as follows: A day before starting to take the pills, two weeks later after starting to take the pills, the last day of taking the pills, and four weeks later after the end of taking the pills. Participants' stool, blood, and urine will be sampled every visit, and grip strength and body composition will also be checked.
Interventions
DIETARY_SUPPLEMENTGI Biome #7
It comprises probiotics (Lactobacillus fermentum, Lactobacillus acidophilus, Lactobacillus plantarum, and Bifidobacterium animalis ssp. lactis) and prebiotics (vitamin B2., Korean red ginseng, and etc.). The administration dosage of probiotics is 5×10\^8 CFU/day.
DIETARY_SUPPLEMENTPlacebo
The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.
Sponsors
GI Biome
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A double-blind, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 60 years old or older * Those who have no difficulties in daily living * Willing to commit throughout the study
Exclusion criteria
* Antibiotics medication in the last month. * Probiotics used in the last months. * Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength Change | 4 weeks | Change from baseline hand grip strength at 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacteroidetes/Firmicutes Ratio Change | 4 weeks | Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks |
| Fasting blood glucose | 4 weeks | Change from baseline fasting blood glucose at 4 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 | 0, 2, 4, 8 weeks | IGF-1 will be quantified from the participants' serum samples. |
| Myostatin | 0, 2, 4, 8 weeks | Myostatin will be quantified from the participants' serum samples. |
| 8-OHdG | 0, 2, 4, 8 weeks | 8-OHdG will be quantified from the participants' serum samples. |
| Fecal acetate level | 0, 2, 4, 8 weeks | Acetate level (short-chain fatty acid) will be measured from the participants' stool. |
| Fecal propionate level | 0, 2, 4, 8 weeks | Propionate level (short-chain fatty acid) will be measured from the participants' stool. |
| Fecal calproate level | 0, 2, 4, 8 weeks | Calproate level (short-chain fatty acid) will be measured from the participants' stool. |
| Fecal valerate level | 0, 2, 4, 8 weeks | Valerate level (short-chain fatty acid) will be measured from the participants' stool. |
| Fecal butyrate level | 0, 2, 4, 8 weeks | Butyrate level (short-chain fatty acid) will be measured from the participants' stool. |
| Walking speed | 0, 2, 4, 8 weeks | The time to walk a 10-m distance will be measured. |
| Gut quotient | 0, 2, 4, 8 weeks | Gut quotient measurement scales will be asked using questionnaires. The minimum and maximum values are 0 and 100, respectively. Higher scores are related to worse gut quotient. |
Countries
South Korea
Outcome results
None listed