Tokyo, Sept. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059121) titled 'The inhibitory effect of NVIF2025-01 intake on fructose absorption' on Sept. 23.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Nagase Viita Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of NVIF2025-01 in suppressing the elevation of postprandial blood fructose concentration.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Placebo drink (a single time intake) -> Washout (not less than 1 week) -> Test drink, containing NVIF2025-01 (a single time intake)
Interventions/Control_2 - Test drink, containing NVIF2025-01 (a single time intake) -> Washout (not less than 1 week) -> Placebo drink (a single time intake)
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Male and female employees of Nagase Vita Co., Ltd. aged 18 to 65 who have been employed for over one year.
2) Those who do not work in shifts for the convenience of subject management.
3) Those who do not smoke or consume excessive alcohol.
4) Those who are not pregnant, may not be pregnant, or are not breastfeeding during the trial period.
5) Those who have no history of conditions or medications that could affect the trial.
6) Those who have never been diagnosed with impaired glucose tolerance or dyslipidemia.
7) Those whose liver function and blood glucose test values from their most recent health checkup are within normal ranges.
8) BMI (Body Mass Index) is included between 18.5 to less than 30.
9) Those who do not experience regular abdominal discomfort.
10) Those who have no allergies to the provided foods.
11) Those who are comfortable with consuming sweet beverages.
12) Those who are considered suitable for participation by the investigator.
Key exclusion criteria - Those who are judged inappropriate for the study by the investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 21 Day
Date of IRB - 2025 Year 04 Month 21 Day
Anticipated trial start date - 2025 Year 09 Month 24 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067630
Disclaimer: Curated by HT Syndication.