UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062755 |
|---|---|
| Receipt number | R000071851 |
| Scientific Title | The Effects of the Medicinal-Food Homology Coix Seed Coarse Grains Beverage supplementation on Chronic Low-grade Systemic Inflammation in overweight or obese Individuals |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/31 19:56:41 |
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Basic information
Public title
The Effects of the Medicinal-Food Homology Coix Seed Coarse Grains Beverage supplementation on Chronic Low-grade Systemic Inflammation in overweight or obese Individuals
Acronym
Medicinal-Food Homology and Chronic Low-grade Systemic Inflammation
Scientific Title
The Effects of the Medicinal-Food Homology Coix Seed Coarse Grains Beverage supplementation on Chronic Low-grade Systemic Inflammation in overweight or obese Individuals
Scientific Title:Acronym
Medicinal-Food Homology and Chronic Low-grade Systemic Inflammation
Region
| Asia(except Japan) |
Condition
Condition
Chronic Low-grade Systemic Inflammation
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of a medicinal-food homology Coix Seed Coarse Grains Beverage on chronic low-grade systemic inflammation in overweight and obese individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
serum high-sensitivity C-reactive protein (hs-CRP) concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
intervention group: Coix Seed Coarse Grains Beverage Group: 20 g per sachet, orally once daily with warm water for 60 days + restricted calorie diet
Interventions/Control_2
control group: restricted calorie diet
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.Adults aged 35-65 years, regardless of sex;
2.Overweight or obesity with a body mass index of 24.0-35.0 kg/m^2;
3.Abnormal chronic low-grade systemic inflammation-related biomarkers, such as an elevated serum high-sensitivity C-reactive protein level above the normal reference range(typically 1.0-3.0 mg/L).
Key exclusion criteria
1.History of allergy or related conditions;
2.Diagnosed autoimmune diseases, severe cardiovascular or cerebrovascular diseases, cancer, hepatic or renal dysfunction, etc.;
3.Use of anti-inflammatory drugs, antibiotics, or weight-loss drugs within 3 months before study initiation;
4.Long-term use of anti-inflammatory supplements, such as fish oil or curcumin;
5.Pregnancy, lactation, or plans for pregnancy;
6.Cognitive impairment or inability to communicate adequately;
7.Surgery or acute/chronic inflammation within the previous 3 months that may affect outcome assessment;
8.Planned relocation, travel, or other circumstances that may prevent completion of follow-up.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kaijun |
| Middle name | |
| Last name | Niu |
Organization
School of Public Health of Tianjin University of Traditional Chinese Medicine
Division name
School of Public Health of Tianjin University of Traditional Chinese Medicine
Zip code
301617
Address
10 Poyanghu Road, West Area, Tuanbo New Town, Jinghai District, Tianjin, China.
TEL
+86-22-59596296
nkj0809@gmail.com
Public contact
Name of contact person
| 1st name | Kaijun |
| Middle name | |
| Last name | Niu |
Organization
Tianjin University of Traditional Chinese Medicine
Division name
School of Public Health of Tianjin University of Traditional Chinese Medicine
Zip code
301617
Address
10 Poyanghu Road, West Area, Tuanbo New Town, Jinghai District, Tianjin, China.
TEL
+86-22-59596296
Homepage URL
nkj0809@gmail.com
Sponsor or person
Institute
School of Public Health of Tianjin University of Traditional Chinese Medicine
Institute
Department
Personal name
Funding Source
Organization
Tianjin University of Traditional Chinese Medicine
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Second Hospital of Tianjin Medical University
Address
No.23 Pingjiang Road, Hexi District, Tianjin
Tel
022-88328832
300211
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 | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 15 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071851
