Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055382) titled 'Verification of intestinal environment improvement by test food' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - MORINAGA & CO., LTD.
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify intestinal environment improvement function of test food
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Test food is taken for 4 weeks
Interventions/Control_2 - Placebo of control 1 is taken for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1) Regular visitor of Matsuike Clinic
2) Women with mild constipation who are prescribed magnesium oxide whose age at the time of obtaining consent to participate in the study is 20 to 64 years old
3) Those who have received sufficient explanation about the purpose and content of this study, have the ability to consent, volunteered to participate voluntarily after understanding well, and can agree to participate in this study in writing
4) Those who can visit the hospital on the designated day and can receive an inquiry
5) Those who are deemed appropriate by the study investigator to participate in this study
Key exclusion criteria - 1) Persons with symptoms other than mild constipation
2) Persons who have no visit history for the past 3 months
3) Those who cannot be judged by the investigator without affecting the participation in the study
4) Persons with food allergies
5) Persons who habitually consume a food (regardless of manufacturer) that falls under the generic name of the test food.
6) Those who plan to become pregnant, breast-feeding, or possibly pregnant, and pregnant during the study period
8) Habitual smokers
7) Persons with alcoholism or other mental disorders
9) Persons who may change their lifestyle during the test period (night work, long trip, etc.)
10) Those who are planning to take health functional foods or supplement foods during the study period
11) Those who have been treated with hospitalization within the past 6 months
12) Persons currently participating in other human clinical trials, those who have not passed 3 months since participating in other human clinical trials
13) Other persons who are deemed inappropriate by the study investigator
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 08 Month 07 Day
Anticipated trial start date - 2024 Year 09 Month 01 Day
Last follow-up date - 2025 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063265
Disclaimer: Curated by HT Syndication.
