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Completed

NCT Number: NCT05735418

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

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University College of Medicine

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GI Biome #7

Dietary Supplement

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

Dietary Supplement

The placebo consists of daily administration of the placebo pills made up of 100% maltodextrin for four weeks.

Primary outcomes

  1. Hand Grip Strength Change

    Time frame: 4 weeks

    Change from baseline hand grip strength at 4 weeks

Secondary outcomes

  1. Bacteroidetes/Firmicutes Ratio Change

    Time frame: 4 weeks

    Change from baseline Bacteroidetes/Firmicutes ratio in gut microbiome at 4 weeks

  2. Fasting blood glucose

    Time frame: 4 weeks

    Change from baseline fasting blood glucose at 4 weeks

Other outcomes

  1. Walking speed

    Time frame: 0, 2, 4, 8 weeks

    The time to walk a 10-m distance will be measured.

  2. Gut quotient

    Time frame: 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.

  3. IGF-1

    Time frame: 0, 2, 4, 8 weeks

    IGF-1 will be quantified from the participants' serum samples.

  4. Myostatin

    Time frame: 0, 2, 4, 8 weeks

    Myostatin will be quantified from the participants' serum samples.

  5. 8-OHdG

    Time frame: 0, 2, 4, 8 weeks

    8-OHdG will be quantified from the participants' serum samples.

  6. Fecal acetate level

    Time frame: 0, 2, 4, 8 weeks

    Acetate level (short-chain fatty acid) will be measured from the participants' stool.

  7. Fecal butyrate level

    Time frame: 0, 2, 4, 8 weeks

    Butyrate level (short-chain fatty acid) will be measured from the participants' stool.

  8. Fecal propionate level

    Time frame: 0, 2, 4, 8 weeks

    Propionate level (short-chain fatty acid) will be measured from the participants' stool.

  9. Fecal calproate level

    Time frame: 0, 2, 4, 8 weeks

    Calproate level (short-chain fatty acid) will be measured from the participants' stool.

  10. Fecal valerate level

    Time frame: 0, 2, 4, 8 weeks

    Valerate level (short-chain fatty acid) will be measured from the participants' stool.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • GI Biome

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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