UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060312 |
|---|---|
| Receipt number | R000068981 |
| Scientific Title | The Effects of Foods Containing Plant Extracts on Resting Energy Metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2026/01/09 20:13:33 |
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Basic information
Public title
The Effects of Foods Containing Plant Extracts on Resting Energy Metabolism
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
The Effects of Foods Containing Plant Extracts on Resting Energy Metabolism
Scientific Title
The Effects of Foods Containing Plant Extracts on Resting Energy Metabolism
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
The Effects of Foods Containing Plant Extracts on Resting Energy Metabolism
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of foods containing plant extracts on Resting Energy Metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat oxidation at rest after 8 weeks of intake
Key secondary outcomes
Other Respiratory gas analysis values at rest after 8 weeks of intake
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Foods containing plant extracts, 8 weeks consumption
Interventions/Control_2
Foods not containing plant extracts, 8 weeks consumption
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy males aged 30 to 60 years-old.
2) Participants whose BMI is under 30.
3) Participants who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing.
Key exclusion criteria
Participants (who or who are)
1) with sleep disorders or chronic insomnia.
2) obese, have hyperlipidemia, or are using medications that may affect lipid metabolism.
3) with a history or current condition of thyroid dysfunction.
4) contract, are under treatment for or have a history of serious diseases (e.g., liver, kidney, digestive, heart, respiratory and endocrine diseases, and other metabolic disorders).
5) with a current history of ENT (ear, nose, and throat) conditions, or those unable to breathe through the nose due to other illnesses.
6) under treatment for or have a history of drug addiction and/or alcoholism.
7) whose weight has fluctuated significantly (plus or minus 5kg or more) within the past year.
8) has a routine of intense exercise.
9) have a history and/or a surgical history of digestive disease affecting digestion and absorption.
10) can't stop using supplements and/or functional foods during the study periods.
11) have declared allergic reaction to ingredients of test food.
12) whose lifestyle habits and daily routines vary frequently.
13) on specific dietary restrictions or a diet, such as fasting, extreme low-carb diets, or veganism.
14) can't stop drinking from 2 days before each measurement.
15) have excessive alcohol intake more than approximately 20 g/day of pure alcohol equivalent for four or more days a week.
16) smokers.
17) shift worker or midnight worker.
18) judged as unsuitable for the study as a research participant by the principal investigator during the screening examination.
19) have donated over 200 mL of blood and/or blood components within the last 1 month, or over 400 mL of blood and/or blood components within the last 3 months of obtaining consent.
20) planning to participate and/or had participated in other clinical studies.
21) judged as unsuitable for the current study by the principal investigator for other reasons.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0004
Address
Anera Bldg. 8F, 3-3-3 Higashi Nihonbashi, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Toyo Shinyaku Co., 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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
| 2026 | Year | 01 | Month | 09 | 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
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 09 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068981
