The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly

Muscle Weakness Clinical Trial

Official title:

A Study on the Effects of Oral Intake of GI Biome #7 on the Intestinal Microbiome and Health in the Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05735418
• Other study ID #: GIB-2022-088
• Status: Completed
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness

Intervention

Dietary Supplement:
• GI 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.
• Placebo
The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	GI Biome

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Walking speed	The time to walk a 10-m distance will be measured.	0, 2, 4, 8 weeks
Other	Gut quotient	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.	0, 2, 4, 8 weeks
Other	IGF-1	IGF-1 will be quantified from the participants' serum samples.	0, 2, 4, 8 weeks
Other	Myostatin	Myostatin will be quantified from the participants' serum samples.	0, 2, 4, 8 weeks
Other	8-OHdG	8-OHdG will be quantified from the participants' serum samples.	0, 2, 4, 8 weeks
Other	Fecal acetate level	Acetate level (short-chain fatty acid) will be measured from the participants' stool.	0, 2, 4, 8 weeks
Other	Fecal butyrate level	Butyrate level (short-chain fatty acid) will be measured from the participants' stool.	0, 2, 4, 8 weeks
Other	Fecal propionate level	Propionate level (short-chain fatty acid) will be measured from the participants' stool.	0, 2, 4, 8 weeks
Other	Fecal calproate level	Calproate level (short-chain fatty acid) will be measured from the participants' stool.	0, 2, 4, 8 weeks
Other	Fecal valerate level	Valerate level (short-chain fatty acid) will be measured from the participants' stool.	0, 2, 4, 8 weeks
Primary	Hand Grip Strength Change	Change from baseline hand grip strength at 4 weeks	4 weeks
Secondary	Bacteroidetes/Firmicutes Ratio Change	Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks	4 weeks
Secondary	Fasting blood glucose	Change from baseline fasting blood glucose at 4 weeks	4 weeks