UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054296 |
|---|---|
| Receipt number | R000062018 |
| Scientific Title | Randomized non-inferiority trial of cumin to turmeric to evaluate its benefit on lipid metabolism and skeletal muscle in men and women over 40 years of age. |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/08/18 09:38:05 |
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Basic information
Public title
Investigation of the effects of cumin on lipid metabolism and skeletal muscle for middle-aged and older adult men and women.
Acronym
Investigation of the effects of cumin on lipid metabolism and skeletal muscle for middle-aged and older adult men and women.
Scientific Title
Randomized non-inferiority trial of cumin to turmeric to evaluate its benefit on lipid metabolism and skeletal muscle in men and women over 40 years of age.
Scientific Title:Acronym
Randomized non-inferiority trial to examine the benefits of cumin on lipid metabolism and skeletal muscle in men and women over 40 years of age.
Region
| Japan |
Condition
Condition
Healthy adult men and women over 40 years old
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of cumin on lipid metabolism and skeletal muscle for middle-aged (middle-aged) and older adult men and women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood tests (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apolipoprotein A-1, apolipoprotein B), body composition
Key secondary outcomes
Gender, age, height, weight, BMI, medical history, medications, allergies, disease information, grip strength, Sit to Stand-5,Fasting blood glucose, HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Group taking 2 g of cumin powder per day for 2 months
Interventions/Control_2
Group taking 2 g of Turmeric powder per day for 2 months
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Momohano Kai staff and family members over 40 years old, or community members who are able to cooperate with the research
Not allergic to cumin, turmeric, or other spices.
Those who do not have serious medical conditions (heart failure, kidney failure, etc.).
Key exclusion criteria
General condition is not stable.
Has a complication (e.g.orthopedic disease, dementia) that significantly affects his/her ability.
Receiving medication (e.g. psychotropic drugs) that significantly affects ability.
Pregnant or possibly pregnant.
Target sample size
80
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
105-8471
Address
3-19-18 Nishi-Shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
ss1135071@jikei.ac.jp
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
0545-36-2000
Homepage URL
eiyouka@momoha.or.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamazaki 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
2024-1
Org. issuing International ID_1
Koyama Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 18 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062018
