Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062980) titled 'Effects of Continuous Oligosaccharide Intake on Vascular Function' on Sept. 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Meiji Co., Ltd
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous oligosaccharide intake for 12 weeks on vascular function by comparison with the intake of a control food.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food (1 sachet, once daily) for 12 weeks
Interventions/Control_2 - Consumption of the placebo food (1 sachet, once daily) for 12 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy men and women aged 20 to less than 65 years at the time of obtaining consent.
2. Participants with a POMS-2 VA (Vigor-Activity) T-score of 50 or lower and an FI (Fatigue-Inertia) T-score of 50 or higher.
3. Participants whose BMI are 18.5 kg/m2 or more and less than 30 kg/m2.
4. Participants who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - 1. Participants who have severe or progressive diseases, such as cardiac-, hepatic-, kidney-, heart-, lung- and digestive- diseases, diabetes mellitus, rheumatoid arthritis, neurological disease, psychiatric disorders, endocrine disease, and other diseases.
2. Participants who exercise at least twice a week.
3. Participants who consume 40 g or more of pure alcohol per day for men or 20 g or more per day for women.
4. Participants with food allergies.
5. Participants who regularly use Foods for Specified Health Uses, foods with function claims, pharmaceuticals, or quasi-drugs that may affect energy metabolism, fatigue, vascular function, glucose metabolism, lipid metabolism, intestinal barrier or immune function, or the intestinal environment.
6. Participants who donate blood or otherwise had more than 200 mL of blood drawn within 1 month or more than 400 mL of blood drawn within 3 months prior to the date of obtaining informed consent.
7. Participants who have a smoking habit.
8. Participants who are pregnant or breastfeeding, or who intend to become pregnant during the study period.
9. Participants who participated in another study involving participants within 1 month prior to the date of informed consent, who are currently participating in another study, or who plan to participate in another study during the study period, except for studies in which participation concurrent with this study is permitted.
10. Participants who are judged unsuitable for this study by principal investigator.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 13 Day
Date of IRB - 2026 Year 08 Month 15 Day
Anticipated trial start date - 2026 Year 09 Month 19 Day
Last follow-up date - 2027 Year 04 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072078
Disclaimer: Curated by HT Syndication.
