UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052232 |
|---|---|
| Receipt number | R000059619 |
| Scientific Title | The interactive effects of nutrient mixtures and probiotics supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a multicenter factorial design trial |
| Date of disclosure of the study information | 2023/09/17 |
| Last modified on | 2023/09/22 21:16:06 |
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Basic information
Public title
The interactive effects of nutrient mixtures and probiotics supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D
insufficiency: a multicenter factorial design trial
Acronym
nutrient mixtures and probiotics supplementation on sarcopenia
Scientific Title
The interactive effects of nutrient mixtures and probiotics supplementation on muscle mass and function among sarcopenic elderly adults with vitamin D insufficiency: a multicenter factorial design trial
Scientific Title:Acronym
nutrient mixtures and probiotics supplementation on sarcopenia
Region
| Asia(except Japan) |
Condition
Condition
sarcopenia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine the interactive effects of nutrient mixtures and probiotics supplementation on muscle mass and function in sarcopenic elderly Chinese adults with vitamin D insufficiency
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences in serum 25(OH)D, grip strength, gait speed, and relative skeletal mass index changes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1.5g low-dose probiotics and 30g regular nutritional supplements (soy milk powder)
Interventions/Control_2
1.5g low-dose probiotics and 30g elderly nutritional supplements(soy milk powder+whey protein+fish oil+vitamin D)
Interventions/Control_3
1.5g probiotics and 30g regular nutritional supplements (soy milk powder)
Interventions/Control_4
1.5g probiotics and 30g elderly nutritional supplements (soy milk powder+whey protein+fish oil+vitamin D)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)participants over 60 years with insufficient vitamin D [serum 25(OH)D concentrations <75nmol/L].
(2)participants with sarcopenia.
Key exclusion criteria
(1) unable to live independently
(2) participants with cardiovascular and cerebrovascular diseases, cancer, dementia
(3) unable to complete the follow-up.
Target sample size
215
Research contact person
Name of lead principal investigator
| 1st name | Kaijun |
| Middle name | |
| Last name | Niu |
Organization
Tianjin Medical University
Division name
Nutrition and epidemiology institution
Zip code
300070
Address
22 Qixiangtai Road, Heping District, Tianjin, P. R.China.
TEL
+86(0)22-83336613
nkj0809@gmail.com
Public contact
Name of contact person
| 1st name | Lirui |
| Middle name | |
| Last name | Jiao |
Organization
Tianjin Medical University
Division name
Nutrition and epidemiology institution
Zip code
300070
Address
22 Qixiangtai Road, Heping District, Tianjin, P. R.China.
TEL
+86(0)22-83336613
Homepage URL
nkj0809@gmail.com
Sponsor or person
Institute
Tianjin Medical University, Nutrition and epidemiology institution
Institute
Department
Personal name
Funding Source
Organization
Tianjin Medical University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tianjin Medical University
Address
22 Qixiangtai Road, Heping District, Tianjin, P. R.China.
Tel
+86(0)22-83336613
nkj0809@gmail.com
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
| 2023 | Year | 09 | Month | 17 | 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
215
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059619
