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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000046604 |
Receipt No. | 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 | 2022/04/01 |
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 |
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Condition | ||
Condition | Healthy subjects | |
Classification by specialty |
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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 |
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Interventions/Control_1 | 4-week ingestion of the test food
Wash out(5 weeks or more) 4-week ingestion of the placebo food |
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Interventions/Control_2 | 4-week ingestion of the placebo food
Wash out(5 weeks or more) 4-week ingestion of the test food |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | HUMA R&D CORP |
Institute | |
Department |
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 |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053101 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |