Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062720) titled 'Effect of Daily Ingestion of Oligosaccharides on Intestinal Environment: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study' on Aug. 28.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Hokkaido Information University
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 4-week continuous ingestion of oligosaccharides on the intestinal environment in a randomized, double-blind, placebo-controlled, crossover study.
In addition, exploratory analyses will evaluate the association between specific gut bacterial counts at screening and subject attributes.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Ingestion of 1 packet (2 g) per day of the test food for 4 weeks, followed by a 4-week washout period, and then ingestion of 1 packet (2 g) per day of the placebo food for 4 weeks.
Interventions/Control_2 - Ingestion of 1 packet (2 g) per day of the placebo food for 4 weeks, followed by a 4-week washout period, and then ingestion of 1 packet (2 g) per day of the test food for 4 weeks.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Those who agree to participate in this study with a written informed consent.
2. Subjects with a relatively low proportion of specific gut bacteria relative to total bacterial count in feces at screening.
Key exclusion criteria - 1. Subjects who are under physician's advice, treatment, and/or medication for obesity, diabetes, and/or dyslipidemia.
2. Subjects with gastrointestinal disorders such as inflammatory bowel disease, irritable bowel syndrome, etc.
3. Subjects with implantable medical devices.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, respiratory, endocrine diseases and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining of obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs or foods.
10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect intestinal environment.
11. Subjects with oligosaccharide intolerance.
12. Subjects whose lifestyle is planned to change during the study.
13. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
14. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks(men), 200 ml whole blood within 4 wks (men and women), or blood components within 2 wks (men and women), prior to the screening.
15. Pregnant or lactating women or those planning to become pregnant.
16. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
17. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 27 Day
Date of IRB - 2026 Year 07 Month 27 Day
Anticipated trial start date - 2026 Year 09 Month 03 Day
Last follow-up date - 2027 Year 05 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071568
Disclaimer: Curated by HT Syndication.
