UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062793 |
|---|---|
| Receipt number | R000071878 |
| Scientific Title | Effects of Cumin Intake on Body Composition and Lipid Metabolism: An Exploratory Randomized Controlled Trial Focusing on Sex Differences |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/09 19:30:46 |
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Basic information
Public title
Effects of Cumin Intake on Body Composition and Lipid Metabolism: An Exploratory Randomized Controlled Trial Focusing on Sex Differences
Acronym
Cumin Sex-Difference RCT
Scientific Title
Effects of Cumin Intake on Body Composition and Lipid Metabolism: An Exploratory Randomized Controlled Trial Focusing on Sex Differences
Scientific Title:Acronym
Cumin Sex-Difference RCT
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of cumin intake on body composition, lipid metabolism, and glycation markers in healthy adults compared with placebo, and to explore potential sex differences in these effects.
Basic objectives2
Others
Basic objectives -Others
To compare the effect of 12-week cumin supplementation with placebo on fat mass as the primary outcome and to evaluate its effects on body composition, lipid metabolism, inflammatory markers, and glycation markers. In addition, potential sex differences in the intervention effects will be explored.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Fat mass at the end of the 12-week intervention
Key secondary outcomes
Body fat percentage, fat-free mass, skeletal muscle mass, skeletal muscle mass index (SMI), fat mass index (FMI), ECW/TBW ratio, phase angle, handgrip strength, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, non-HDL cholesterol, HbA1c, glycated albumin, pentosidine, high-sensitivity C-reactive protein (hs-CRP), high-sensitivity interleukin-6 (hs-IL-6), and skin advanced glycation end products (AGEs). Sex differences in the intervention effects (intervention-by-sex interaction) will also be explored.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will take one soft capsule containing essential oil extracted from cumin (equivalent to 3.0-4.0 g of cumin powder) once daily for 12 weeks. No specific timing of intake will be required, and participants will be instructed to maintain their usual dietary and exercise habits throughout the study.
Interventions/Control_2
Participants will take one placebo soft capsule containing no cumin once daily for 12 weeks. No specific timing of intake will be required, and participants will be instructed to maintain their usual dietary and exercise habits throughout the study.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women aged 30 years or older and younger than 65 years.
2. Individuals with a body mass index (BMI) of 22 kg/m2 or higher and 30 kg/m2 or lower.
3. Individuals who have received sufficient information about the study and provided voluntary informed consent to participate.
Key exclusion criteria
1. Individuals younger than 30 years or aged 65 years or older.
2. Individuals with a BMI lower than 22 kg/m2 or higher than 30 kg/m2.
3. Individuals who have newly initiated a diet, exercise program, or supplement use for weight loss within 3 months before the start of the study.
4. Individuals currently using medications that may affect body weight, fat mass, glucose metabolism, or lipid metabolism, including antidiabetic drugs, anti-obesity drugs, corticosteroids, and GLP-1 receptor agonists.
5. Individuals with serious underlying diseases, including severe liver, kidney, or heart disease, malignancy, active infection, or autoimmune disease, considered inappropriate for participation by the investigator.
6. Women who are pregnant, breastfeeding, or may be pregnant.
7. Individuals unable to avoid daily consumption of foods containing curry powder during the study period.
8. Individuals with a history of allergy to cumin or any component of the study product, including gelatin.
9. Individuals considered unable to continue consuming the study product because of gastrointestinal symptoms or gastrointestinal diseases.
10. Individuals for whom InBody measurements cannot be appropriately performed, such as those with a cardiac pacemaker.
11. Individuals currently participating or planning to participate in another interventional study during the study period.
12. Individuals considered inappropriate for participation by the principal investigator or other investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Suzuki |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
ss1135071@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Suzuki |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
ss1135071@jikei.z
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Shin Suzuki
Funding Source
Organization
S&B Foods Inc.
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
Koyama Rehabilitation Hospital
Address
405-25 Obuchi, Fuji, Shizuoka
Tel
0545-36-2000
koyama-hp@momoha.or.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
湖山リハビリテーション病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071878
