Tokyo, Jan. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060072) titled 'Effect of food-containing ingredients on increasing lipid consumption at rest' on Jan. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Suntory beverage & Food limited.
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of continuous intake of food components on increasing resting lipid consumption
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingredient-containing food (8 weeks)
Interventions/Control_2 - Ingredient-free food (8 weeks)
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Healthy men and women who are 20 <= years old <65.
(2) Subject who can come to the facility on the designated day.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria - (1) Subjects whose systolic pressure <90 mmHg.
(2) Subjects in pregnancy or lactation
(3) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(4) Subjects who are applicable to following items
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c) Subjects who are contracting diabetes.
d) Subjects with a history of cancer, tuberculosis, or other serious illness
(5) Subjects who have an unsteady lifestyle because of a working shift or a night shift.
(6) Smoker
(7) Subjects who drink a lot.
(8) Subjects whose BMI is less the 18.5 or over 30.0
(9) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target Size - 128
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 15 Day
Date of IRB - 2025 Year 11 Month 15 Day
Anticipated trial start date - 2026 Year 01 Month 08 Day
Last follow-up date - 2026 Year 04 Month 02 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068563
Disclaimer: Curated by HT Syndication.