UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057446 |
|---|---|
| Receipt number | R000065634 |
| Scientific Title | Sex-Specific Effects of Cumin Supplementation on Body Composition, Lipid, and Glycemic Profiles: A Pilot Study |
| Date of disclosure of the study information | 2025/03/29 |
| Last modified on | 2025/03/29 15:38:04 |
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Basic information
Public title
Sex-Specific Effects of Cumin Supplementation on Body Composition, Lipid, and Glycemic Profiles: A Pilot Study
Acronym
Effects of Cumin Intake on Muscle Mass and Muscle Quality in Adult Men and Women
Scientific Title
Sex-Specific Effects of Cumin Supplementation on Body Composition, Lipid, and Glycemic Profiles: A Pilot Study
Scientific Title:Acronym
Exploratory Study on Sex Differences in the Effects of Cumin on Muscle Quality
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of cumin (Cuminum cyminum L.) intake on muscle mass, muscle quality (e.g., ECW/TBW ratio, phase angle), and lipid/glucose metabolism in healthy adults, with a focus on exploring potential sex differences
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Change in LDL cholesterol level (from baseline to 2 months post-intervention)
Key secondary outcomes
Changes in ECW/TBW ratio, phase angle, HDL cholesterol, HbA1c, etc.Comparison of effects by sex
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of 2 g of cumin powder for 2 months
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults
No known allergy to cumin or other Apiaceae family plants
Provided written informed consent for participation
Key exclusion criteria
Individuals with severe medical conditions such as heart or renal failure
Individuals taking medications affecting lipid or glucose metabolism
Pregnant or possibly pregnant individuals
Individuals with cumin allergy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Suzuki |
Organization
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@gmail.com
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kurata |
Organization
Koyama Rehabilitation Hospital
Division name
Department of Nutrition
Zip code
417-0801
Address
405-25 Ohbuchi, Fuji City, Shizuoka Prefecture
TEL
08056591135
Homepage URL
eiyouka@momoha.or.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Shin Suzuki
Funding Source
Organization
amazaki Spice Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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 Ohbuchi, Fuji City, Shizuoka Prefecture
Tel
0545-36-2000
eiyouka@momoha.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-1
Org. issuing International ID_1
Koyama Rehabilitation Hospital
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
| 2025 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.momoha.or.jp/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.momoha.or.jp/
Number of participants that the trial has enrolled
29
Results
In women, a decrease in the extracellular-to-total body water ratio (ECW/TBW) and an increase in phase angle were observed, suggesting improvements in muscle quality.Low-density lipoprotein cholesterol (LDL-C) levels significantly decreased in both men and women.These findings suggest that the health effects of cumin intake may differ by sex, offering new insights for personalized nutrition guidance and the use of spices in health promotion.
Results date posted
| 2025 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults
Participant flow
Recruitment was conducted among hospital staff.
Adverse events
non
Outcome measures
Change in LDL cholesterol leve,ECW/TBW ratio, phase angle, HDL cholesterol, HbA1c, etc.
Comparison of effects by sex
Plan to share IPD
non
IPD sharing Plan description
non
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | 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
| 2025 | Year | 03 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065634
