UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046861 |
|---|---|
| Receipt number | R000053461 |
| Scientific Title | Effects of continuous intake of dietary components on body composition and function under the condition of maintaining food intake |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2024/04/02 12:46:50 |
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Basic information
Public title
Effects of continuous intake of dietary components on body composition and function under the condition of maintaining food intake
Acronym
Effects of continuous intake of dietary components on body composition and function under the condition of maintaining food intake
Scientific Title
Effects of continuous intake of dietary components on body composition and function under the condition of maintaining food intake
Scientific Title:Acronym
Effects of continuous intake of dietary components on body composition and function under the condition of maintaining food intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on body composition and function of test foods with different dietary components for 12 weeks in healthy middle-aged and elderly subjects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension muscle strength test, Grip strength test, timed up & go test.
Key secondary outcomes
(Secondary outcomes)
Health-related quality of life, body composition, balance function and plantar pressure.
(Safety evaluation)
Vital signs, physical measurements (weight, BMI), adverse events.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the placebo foods for 12 weeks.
Interventions/Control_2
Continuous intake of the test foods A for 12 weeks.
Interventions/Control_3
Continuous intake of the test foods B for 12 weeks.
Interventions/Control_4
Continuous intake of the test foods C for 12 weeks.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged between 60 and 75 years old at the time of obtaining written consent.
2.Subject with BMI >=19kg/m2 and <24kg/m2.
3.Subject who is exercise or walking less than once a week and for less than 30 minutes each time.
4.Subject who does not provide childcare or nursing care on a daily basis (more than 4 hours per week).
5.Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Key exclusion criteria
1.Subject who has been instructed by a doctor to refrain from walking or exercise.
2.Subject who is taking medication or under medical treatment due to serious illness.
3.Subject who is under exercise therapy or dietetic therapy.
4.Subject who may develop allergies by raw materials for test foods (soybeans, shrimp, crab, wheat, milk, eggs, almonds, squid, oranges, cashew nuts, kiwifruit, beef, sesame, salmon, mackerel, chicken, bananas, pork, peaches, Japanese yam, apples, gelatin).
5.Subject with current or history of drug or alcohol dependence.
6.Subject who attends a hospital due to mental disorders (depression, etc.) or sleep disorders (Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past.
7.Subject who is current smokers or those who have had a smoking habit for the past 3 months.
8.Subject whose working hours are irregular due to night shifts, etc.
9.Subject who has extremely irregular lifestyle habits such as eating and sleeping.
10.Subject who has an extremely unbalanced diet.
11.Subject who had a weight fluctuation of +- 5 kg or more within 3 months.
12.Subject with knee surgery or disease, or those who use a cane on a daily basis.
13.Subject with serious current or history of brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases.
14.Subject who has used and are still using supplements or medications that affect muscle strength/muscle, gait function, or fatigue reduction within the past 3 months.
15.Subject who has consumed and are currently consuming healthy oils (coconut oil, MCT oil, etc.) that may have enhanced the dietary components being evaluated dating back to the past 3 months.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Yoga Allergy Clinic
Address
4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel
03-5491-4478
jim@medipharma.co.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
| 2022 | Year | 02 | Month | 08 | 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
120
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
| 2022 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 19 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
16.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
17.Subject who has blood collection or donation more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition.
18.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
19Subject who has difficulty observing records on various survey forms.
20.Subject who is judged as an inappropriate candidate according to the screening data.
21.Subject who is considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053461
