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

Not Applicable

Completed

• Conditions: Muscle Weakness
• Interventions: Dietary Supplement: GI Biome #7; Dietary Supplement: Placebo

• Registration Number: NCT05735418
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2023-01-13
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Primary Completion: 2023-04-27
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GI Biome #7	GI Biome #7	The intervention consists of daily administration of probiotics GI Biome #7 for four weeks.
Placebo	Placebo	The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.

Primary Outcome Measures

Name	Time	Method
Hand Grip Strength Change	4 weeks	Change from baseline hand grip strength at 4 weeks

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose	4 weeks	Change from baseline fasting blood glucose at 4 weeks
Bacteroidetes/Firmicutes Ratio Change	4 weeks	Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks

Trial Locations

Locations (1)

Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of