UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051636 |
|---|---|
| Receipt number | R000057870 |
| Scientific Title | The influence of taking the pyrroloquinoline quinone containing food or the spermidine containing food( dried yeast GSP23) in accumulation of the body fat and the muscles in human study.(pilot study) |
| Date of disclosure of the study information | 2023/07/30 |
| Last modified on | 2023/07/18 17:01:01 |
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Basic information
Public title
The influence of taking the pyrroloquinoline quinone containing food or the spermidine containing food( dried yeast GSP23) in accumulation of the body fat and the muscles in human study.(pilot study)
Acronym
The influence of PQQ or the spermidine containing food in accumulation of the body fat and muscles in human study (pilot study)
Scientific Title
The influence of taking the pyrroloquinoline quinone containing food or the spermidine containing food( dried yeast GSP23) in accumulation of the body fat and the muscles in human study.(pilot study)
Scientific Title:Acronym
The influence of PQQ or the spermidine containing food in accumulation of the body fat and muscles in human study (pilot study)
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been suggested that pyrroloquinoline quinone (PQQ) intake may suppress fat accumulation and spermidine intake may increase muscle mass. Therefore, we compared the effects of foods already on the market in three groups, including the control group, for their usefulness in sarcopenia and obesity. The purpose was to conduct it on healthy subjects as a preliminary study stage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consume the prescribed food for 8 weeks, observe at 3 points before intake, 4 and 8 weeks after, and compare the usefulness.
The primary outcomes are body composition measurements and changes in upper arm midpoint circumference and lower limb circumference.
Key secondary outcomes
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Pyrroloqunoline quinone disodium sali(PQQ) containing foods consumed for 8 weeks
PQQ:25mg,Starch:175mg, Weight per capsule 200mg
Interventions/Control_2
Spermidine-containing foods (dried sake yeast strain GSP23)
Spermidine-containing foods (dried sake yeast strain GSP23): 150mg
Starch: 50mg
Weight per capsule: 200mg
Interventions/Control_3
Placebo food Starch: 175mg Weight per capsule: 175mg
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and postmenopausal women who are 50 years old or older, 75 years old or younger who have not been treated for diseases
(2) BMI of 22.0 kg/m2 or more and less than 30.0 kg/m2
(3) Those who are considered to have an effect on fat, such as fat burning, or who have not taken supplements, tea, etc. that may affect muscles within one month before the start of the study.
Key exclusion criteria
(1) Those who are treating serious diseases (heart disease, liver disease, diabetes, kidney disease, etc.) and mental disorders such as depression, and those who have a medical history.
(2) Those who may be allergic to the test food (sake lees, gelatin, etc.)
(3) Those who are allergic to alcohol
(4) Those who have significant changes in diet and exercise and are unable to maintain a constant daily lifestyle.
(5) Those who work in shifts or work late night shifts
(6) Those who take natto at least twice a week (because it contains a lot of PQQ and polyamine)
(7) Those who have participated in other clinical trials within the past 1 month
(8) Other persons who are judged to be ineligible by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ishihara |
Organization
Kagawa Nutrition University
Division name
KNU Nutirition Cinic
Zip code
1708481
Address
3-24-3,Komagome,Toshimaku,Tokyo.
TEL
03-3918-6181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
KNU Nutrition Clinic
Zip code
170-8481
Address
3-24-3,Komagome,Toshima,Tokyo.
TEL
03-3918-6181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi GAS Chemical Company,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
Kagawa Nutrition University
Address
3-9-21,Chiyoda,Sakado,Saitama
Tel
049-283-2131
clinic@eiyo.ac.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
女子栄養大学 栄養クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
56
Results
No significant changes were obtained in any of the three groups.
Results date posted
| 2023 | Year | 07 | Month | 18 | Day |
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
| 2023 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 18 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057870
