UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055055 |
|---|---|
| Receipt number | R000062894 |
| Scientific Title | A New Approach to Prevent the Progression of Frailty in Prefrail Elderly Individuals through Agarooligosaccharide Intervention (Second Phase):Randomized Clinical Trial |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2025/11/13 09:15:19 |
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Basic information
Public title
A New Approach to Prevent the Progression of Frailty in Prefrail Elderly Individuals through Agarooligosaccharide Intervention (Second Phase)
Acronym
Second Phase of the Clinical Trial to Inhibit the Progression of Prefrailty
Scientific Title
A New Approach to Prevent the Progression of Frailty in Prefrail Elderly Individuals through Agarooligosaccharide Intervention (Second Phase):Randomized Clinical Trial
Scientific Title:Acronym
Second Phase of the Clinical Trial to Inhibit the Progression of Prefrailty
Region
| Japan |
Condition
Condition
Prefrailty or frailty
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is a randomized controlled trial (RCT) aimed at preventing the progression of prefrailty to frailty (weakness) in elderly individuals through the intake of functional foods. The trial seeks to demonstrate that the daily intake of functional food Agaro-Oligosaccharides (AOSs) can reduce walking speed and muscle strength decline in prefrail elderly individuals, thereby reversibly inhibiting the progression to frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
10 meter walking test
Key secondary outcomes
Taking 500mg/day AOSs or Placebo for 12 weeks
10-meter walking speed
30-second chair stand test
Timed Up and Go test
Lower limb muscle strength
Grip strength
Blood pressure
Pain score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Taking 500mg/day of Agarooligosaccharide for 12 weeks
Interventions/Control_2
Taking Placebo for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
"Individuals scoring 4 or more points on the 25-item frailty checklist"
Key exclusion criteria
People with high blood pressure
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | RYOJI |
| Middle name | |
| Last name | HIROTA |
Organization
Matsumoo university
Division name
Department of Nutrition
Zip code
3901241
Address
2095-1, Niimura, Matsumoto, Nagano
TEL
0263487200
ryoryo2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | RYOJI |
| Middle name | |
| Last name | HIROTA |
Organization
Matsumoo university
Division name
Department of Nutrition
Zip code
3901241
Address
2095-1, Niimura, Matsumoto, Nagano
TEL
09036969547
Homepage URL
https://www.matsumoto-u.ac.jp/professors/pid22140.php
ryoryo2003@yahoo.co.jp
Sponsor or person
Institute
Matsumoto university
Institute
Department
Personal name
Funding Source
Organization
Matsumoto university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsumoo university
Address
2095-1, Niimura, Matsumoto, Nagano
Tel
0263487200
ryoji.hirota@t.mastu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Background: Frailty and sarcopenia are major health issues among older women. Agaro-oligosaccharides (AGO), low-molecular-weight carbohydrates derived from agarose, exhibit anti-inflammatory and antioxidant activities that may support muscle maintenance.
Methods: In this 12-week randomized, double-blind, placebo-controlled trial, 23 community-dwelling older women (AGO n = 12; placebo n = 11) received AGO (500 mg/day) or placebo. Outcomes included 10-m walking speed, grip strength, 30-second chair-stand test (CS-30), timed up-and-go (TUG), and lower-limb circumferences.
Results: At week 6, the AGO group showed a greater increase in left-hand grip strength than placebo (change = +1.2 +/- 1.5 kg vs -0.5 +/- 1.4 kg; p = 0.020) and a greater increase in right calf circumference (change = +0.6 +/- 1.3 cm vs -1.1 +/- 1.3 cm; p = 0.008). In the pre-frail subgroup (frailty score >= 4; n = 9), left-hand grip strength improved significantly with AGO (change = +1.8 +/- 1.8 kg; p = 0.049). Between-group differences were not significant at week 12, although directions of change remained favorable in the AGO group. No serious adverse events occurred.
Conclusions: AGO supplementation (500 mg/day) was well tolerated and associated with short-term improvements in muscle strength and calf circumference among older women, with signals stronger in pre-frail participants. Larger, longer trials are warranted to confirm durability and clinical relevance.
Keywords: agaro-oligosaccharides; sarcopenia; frailty; older women; randomized controlled trial; muscle strength
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062894
