UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052813 |
|---|---|
| Receipt number | R000060258 |
| Scientific Title | A randomized, double-blind, placebo-controlled crossover clinical trial of mineral absorption by lactulose intake in adults. |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2025/02/13 14:10:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical trial on the effect of lactulose on mineral absorption.
Acronym
A clinical trial of lactulose.
Scientific Title
A randomized, double-blind, placebo-controlled crossover clinical trial of mineral absorption by lactulose intake in adults.
Scientific Title:Acronym
A clinical trial of mineral absorption by lactulose intake in adults.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of lactulose intake on enhancing the mineral absorption.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary mineral content
Key secondary outcomes
Gut microbiota
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of lactulose for 2 weeks
Interventions/Control_2
Intake of placebo for 2 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult males aged 20-64 years and adult females aged 45-64 years who were at least one year past menopause
Key exclusion criteria
1)Subjects undergoing treatment for liver, kidney, heart, lung, gastrointestinal, hematological, endocrine, and infectious diseases, or those with a serious history of these diseases.
2)Subjects with a history of gastrointestinal resection (excluding appendicitis).
3)Subjects with gastrointestinal dysfunction such as irritable bowel syndrome or inflammatory bowel disease.
4)Subjects who regularly use medicine that affect the gut microbiota or bone metabolism (antibiotics, active biopharmaceuticals, laxatives, active vitamin D3, etc.)
5)Subjects who regularly use food with functional claims that improve the gut microbiota or maintain bone density or improve bone metabolism or promote mineral absorption, or foods containing vitamin D3 or mineral.
6)Subjects with serious allergies to medicines and food.
7)Subjects with lactose intolerance.
8)Subjects who participate in another clinical study within 3months before providing written consent to participate in the present study.
9)Subjects who are judged inappropriate for the study by principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 17 | 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
| 2023 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060258
