UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051444 |
|---|---|
| Receipt number | R000058677 |
| Scientific Title | The difference in efficacy of octanoic acid and decanoic acid, medium-chain fatty acids. |
| Date of disclosure of the study information | 2023/06/27 |
| Last modified on | 2023/06/26 15:36:09 |
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Basic information
Public title
About the difference in efficacy depending on the carbon number of medium-chain fatty acids
Acronym
Effects of medium-chain fatty acid carbon number on muscle function, cognitive function, and feeding and swallowing function.
Scientific Title
The difference in efficacy of octanoic acid and decanoic acid, medium-chain fatty acids.
Scientific Title:Acronym
The difference in efficacy of octanoic acid and decanoic acid, medium-chain fatty acids.
Region
| Japan |
Condition
Condition
Frail elderly subjects
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the number of carbons of medium-chain fatty acids has an effect on the improvement of muscle function, cognitive function, and feeding and swallowing function in the elde.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in physical function, cognitive function, and swallowing function will be compared before and after 1.5 months of intervention. Body measurements and body composition will be estimated by body weight, body mass index (BMI), body fat percentage, body fat mass, skeletal muscle mass, upper arm circumference (AC), triceps subcutaneous fat thickness (TSF), upper arm muscle circumference (AMC), upper arm muscle area (AMA), and lower leg circumference (CC). Physical performance is estimated by grip strength, maximum walking speed, number of repetitive openings and closings of the lower extremities, quadriceps endurance, lower extremity muscle strength, respiratory muscle function (peak flow meter), and functional independence measures (FIM). Cognitive function is estimated with the Mini-Mental State Examination (MMSE) and the N Mental State Rating Scale for the Elderly (NM scale).
Eating and swallowing function is estimated with the Repeated Saliva Swallowing Test (RSST), the Revised Water Swallowing Test (MWST), and tongue pressure muscle strength.
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The first group is the "octanoate group" that takes MCT (C8:0). C8:0 Mix 6 g (54 kcal) of MCT containing about 97% with rice or miso soup and take it for lunch. The intervention will last approximately 1.5 months.
Interventions/Control_2
The second group is the "decanoic acid group" taking MCT (C10:0). C10:0 Mix 6 g (54 kcal) of MCT containing about 97% with rice or miso soup and take it for lunch. The intervention will last approximately 1.5 months.
Interventions/Control_3
The third group is the "LCT group," that takes LCT. LCT is mixed with rice or miso soup and consumed for lunch. The intervention will last approximately 1.5 months.
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
Elderly subjects in a nursing care home for the elderly volunteered to participate in a 3-mo dietary supplement intervention program. All residents in this nursing care home need special care by other people for living. They are classified into Japanese nursing care levels with number between 1 and 5 based on assessed care needs.
Key exclusion criteria
Those in need of enteral or intravenous nutritional therapy. Patients who have severe dysphagia and cannot take food orally. Those who have a level of consciousness rating (JCS: Japan coma scale) of 2-2 or higher. Type I diabetes mellitus and those with serious cardiac, hepatic, renal, or hematological diseases. Fasting blood glucose level of 200 mg/dl or higher. CRP 2.0 mg/dl or higher. Persons who frequently fall ill. BMI 25.0 kg/m2 or higher. Subjects with relevant food allergies. Persons who are unable to understand the study. Persons who are judged not to be included in the study by the facility director, who is the facility physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Department of Food and Nutrition, Faculty of Contemporary Human Life Science
Zip code
631-8585
Address
3-1-3 Gakuenminami, nara-shi, nara-ken, Japan
TEL
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Department of Food and Nutrition, Faculty of Contemporary Human Life Science
Zip code
631-8585
Address
3-1-3 Gakuenminami, nara-shi, nara-ken, Japan
TEL
0742-41-4742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
Tezukayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezukayama University
Address
3-1-3 Gakuenminami, nara-shi, nara-ken, Japan
Tel
0742414742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
04-42
Org. issuing International ID_1
Tezukayama University Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
介護老人保健施設 大和田の里(奈良県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 20 | 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 | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058677
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