UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046604 |
|---|---|
| Receipt number | R000053101 |
| Scientific Title | Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions |
| Date of disclosure of the study information | 2022/01/13 |
| Last modified on | 2024/01/09 16:26:14 |
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Basic information
Public title
Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Acronym
Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Scientific Title
Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Scientific Title:Acronym
Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on postprandial substrate metabolism during rest and exercise, middle-aged and elderly pre-obese who do not have exercise habits ingest test diets with different dietary components continuously for 4-weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stable isotope excretion after test meals (during rest), fatty acid conversion, respiratory exchange ratio (during exercise)
Key secondary outcomes
(Secondary outcomes)
Postprandial body heat production (during rest), carbohydrate oxidation (during exercise), visceral fat measurement, heart rate variability
(Safety evaluation)
Vital signs, body measurements(weight,BMI), adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
4-week ingestion of the test food
Wash out(5 weeks or more)
4-week ingestion of the placebo food
Interventions/Control_2
4-week ingestion of the placebo food
Wash out(5 weeks or more)
4-week ingestion of the test food
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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Japanese men and women aged between 35 and 65 years old at the time of obtaining written consent.
2)Subject with BMI >=25kg/m2 and <30kg/m2.
3)Non-smoker
4)Subject with alcohol intake less than 30g/day.
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 is taking medication or under medical treatment due to serious illness.
2.Subject who has experienced chest pain or abnormal pulse at rest.
3.Subject who is under exercise therapy or dietetic therapy.
4.Subject with serious current illness or complications or history such as heart disease, liver disease, kidney disease, cardiovascular disease, blood disease, etc.
5.Subject who is receiving the rheumatism treatment.
6.Subject who frequently has shortness of breath, lightheadedness, dizziness or loss of consciousness.
7.Subject who might has or has a history of drug allergies, food allergies, allergies to test foods, or allergies to raw materials for evaluated foods(soybeans, milk protein, pork).
8.Subject who has difficulty ingesting test foods and evaluation foods.
9.Subject who has a family member who died suddenly of unknown causes.
10.Subject who has been diagnosed as having problems with the legs and hips.
11.Subject who feels pain in their hips, knees, or body when ascending or descending stairs, etc.
12.Subject with knee surgery or disease, or those who use a cane on a daily basis.
13.Subject with current or history of drug or alcohol dependence.
14.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.
15.Subject who exercises for the purpose of maintaining or improving their physical fitness for a total of 60 minutes or more per week.
Target sample size
30
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 | 01 | Month | 13 | 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
30
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
| 2021 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 12 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 24 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
16.Subject who performs physical labor for a total of 10 hours or more per week.
17.Subject whose working hours are irregular due to night shifts, etc.
18.Subject with a weight fluctuation of more than +-5 kg within 2 months.
19.Subject who has extremely irregular lifestyle habits such as eating and sleeping.
20.Subject who has an extremely unbalanced diet.
21.Subject who are using or cannot stop using health foods, supplements, or medicines that affect fatigue reduction, fat burning and obesity control.
22.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.
23.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.
24.Subject who plans or wish to donate blood or get vaccinated during the test period. However, this does not apply to vaccination against the new coronavirus.
25.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
26.Subject who has difficulty observing records on various survey forms.
27.Subject who is judged as an inappropriate candidate according to the screening data.
28.Subject who is considered as an inappropriate candidate by the doctor in charge.
Management information
Registered date
| 2022 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053101
