Clinical Trial: Study on the Mitigating Effect of Test Food Intake on Edema - A randomized, double-blind, placebo-controlled, crossover study- (Japan)

Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062595) titled 'Study on the Mitigating Effect of Test Food Intake on Edema - A randomized, double-blind, placebo-controlled, crossover study-' on Aug. 19.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - feileB Co., Ltd

Condition: Condition - Healthy men and women aged 20 to 64 Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of continuous intake of a food product containing 100 mg of Ginger Extract Powder E on facial puffiness in healthy male and female subjects aged 20 to 64 who perceive facial puffiness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Test food intake Interventions/Control_2 - Control food intake

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1)Healthy male and female subjects aged 20 to under 65 years. 2)Subjects who subjectively perceive facial swelling. 3)Subjects who fully understand the purpose and content of the study and provide written informed consent of their own free will. Key exclusion criteria - 1)Subjects with a history or current diagnosis of diabetes, hepatic disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious diseases 2)Subjects who have undergone gastrointestinal surgery, excluding minor procedures (e.g., appendectomy) judged by the principal investigator to have no impact on the study 3)Subjects with clinically significant abnormalities in liver or renal function tests at screening 4)Subjects currently undergoing treatment for any disease 5)Subjects with a history of severe allergy to foods or medications, or with a known allergy to ginger 6)Subjects presenting with symptoms of anemia 7)Women who are pregnant, lactating, possibly pregnant, or planning to become pregnant during the study period 8)Subjects using hormonal agents or low-dose oral contraceptives 9)Subjects who engage in regular strenuous exercise, or those currently on a weight-loss diet 10)Subjects unable to abstain during the study period from health foods (including Foods for Specified Health Uses [FOSHU] and Foods with Function Claims), quasi-drugs, or foods/supplements claiming to improve swelling, blood flow, or sensitivity to cold, or claiming to have diuretic effects 11)Subjects undergoing continuous treatment with medications (including over-the-counter [OTC] and prescription drugs), excluding cases judged by the principal investigator to have no impact on the study 12)Subjects currently participating in, or scheduled to participate in, other clinical studies at the start of this study 13)Subjects judged unsuitable as participants based on the lifestyle questionnaire, medical interview, or screening test results 14)Subjects otherwise judged unsuitable for the study by the principal investigator Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 22 Day Date of IRB - 2026 Year 08 Month 06 Day Anticipated trial start date - 2026 Year 08 Month 20 Day Last follow-up date - 2026 Year 12 Month 24 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071652

Disclaimer: Curated by HT Syndication.