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Efficacy of Heat-Killed Bifidobacterium supplementation in patients of sarcopenia

A Single-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Muscular strength increase effects of Heat-Killed Bifidobacterium supplementation in patients of sarcopenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200200
Enrollment
100
Registered
2020-11-13
Start date
2021-04-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia Sarcopenia Intestinal bacteria

Interventions

By half is randomly assigned in one of the Biffidobacterium group or the placebo groups and takes in each examination food for 24 weeks
Intake of the examination food

Sponsors

Asaoka Daisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)The age at agreement acquisition is man and woman younger than 90 years 50 years old or older (2)1 or 2 or both concretely following correspond and the patient whom sarcopenia was diagnosed in by the sarcopenia diagnosis that Asian Working Group for Sarcopenia proposes correspond to 3 AWGS 2019 1.A grip drop Male <28kg, woman <18kg 2.A walking speed drop <1.0 m/sec 3.By the measurement of the quantity of muscle the drop (male <7.0 kg/m2, woman <5.4 kg/m2) of the skeletal muscle mass index (SMI) by the DXA method (3)Written informed consent is provided about the participation in this study.

Exclusion criteria

Exclusion criteria: 1. When there is the head injury that left Parkinson's disease, Huntington disease, original ordinary pressure hydrocephalus, progressive supranuclear paralysis, epilepsy, multiple sclerosis, intracranial infectious disease, aftereffects. 2. When there is the past of major depression and bipolar disorder, alcohol and other drug dependency. 3. When frequent occurrence cerebral infarction, a brain tumor, an endocranium bloody bowel discharge tumor are detected. 4. In the case of dementia. 5. In the case of neurologic syphilis. 6. When there are exercise restrictions by a disease of joint. 7. The person who is infected with the infectious diseases that serious cerebro-vascular disease, heart trouble, liver disease, renal disease, a digestive organ disease, an internal secretion metabolism disease, a report need. 8. A person with a history of the past of the gastrointestinal advanced cancer or the person who is receiving treatment, medication because of the disease now. 9. The person with a history of the operation big to gastric resection, the stomach and intestines suture, alimentary system including the intestinal tract excision. 10. A person having a digestive organs disorder such as the inflammatory bowels syndrome. 11. Pharmaceutical products (antibiotic, medicine for intestinal disorders, aperient, binding medicine) and supplement (a person using a bifidus bacillus regularly, which affect the bowel movement 12. The person who might show an allergic symptom for a drug or food. 13. A habitual user of excessive smoking and the alcohol and the person that lifestyles such as a meal, the sleep are extremely irregular. 14. When I take antidementia medicine, psychotropic drug (antidepressant, antipsychotic). 15. When, having severe diabetes, I give insulin. 16. When I work on resistance 17. In addition, when I recognize it being to if a study responsibility doctor is inadequate.

Design outcomes

Primary

MeasureTime frame
the amount of change in intake 24 weeks from a baseline of the knee extension muscular strength

Secondary

MeasureTime frame
(1)Evaluation of the body composition (the DXA method) a skeletal muscle mass index: It is a rate of change, the amount of change in intake 24 weeks from SMI (Skeletal Muscle Mass Index) (kg/m2), a baseline of the SMI (the DEXA method) is a rate of change, the amount of change in intake 24 weeks from limbs skeletal muscle mass (kg), the baseline of the limbs skeletal muscle mass (the DEXA method) is a rate of change, the amount of change in intake 24 weeks from quantity of non-fat (kg), a baseline of the quantity of non-fat (the DEXA method) is a rate of change, the amount of change in intake 24 weeks from lumbar vertebrae, a thighbone neck (BMD, YAM(%), T-score, Z-score), the baseline of lumbar vertebrae, the thighbone neck (BMD, YAM(%), T-score, Z-score) (the BIA method) a skeletal muscle mass index: It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from SMI (Skeletal Muscle Mass Index) (kg/m2), a baseline of the SMI (the BIA method) is a rate of change, the amount of change in intake 12 weeks, 24 weeks from limbs skeletal muscle mass (kg), the baseline of the limbs skeletal muscle mass (the BIA method) is a rate of change, the amount of change in intake 12 weeks, 24 weeks from a phase angle, the baseline of the phase angle (2)Evaluation of the muscular strength It is the rate of change in intake 24 weeks from knee extension muscular strength, a baseline of the knee extension muscular strength It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from grip (kg), the baseline of the grip It is a rate of change, the amount of change in intake 12 weeks, 24 weeks from temporarily physical ability battery (Short Physical Performance Battery: SPPB), a baseline of SPPB (3)Evaluation of the body function It is usually a rate of change, the amount of change in intake 12 weeks, 24 weeks from a walking speed, the baseline of the normal walking speed (4)I extract DNA from enterobacterial flora analysis, the feces before and after a

Contacts

Public ContactDaisuke Asaoka

Juntendo Tokyo Koto Geriatric Medical Center

daisuke@juntendo.ac.jp+81-3-5632-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026