Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060260) titled 'Long-term efficacy of the test food on obesity-related indices: A randomized, double-blind, placebo-controlled parallel-group study' on Jan. 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co. Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The study aims to assess the impact of prolonged intake of Trp colon-targeted delivery formulation on obesity-related indices in healthy adults, focusing on abdominal visceral fat area.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ingestion of test food, 1 sachet daily for 16 weeks
Interventions/Control_2 - Ingestion of placebo food, 1 sachet daily for 16 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.Healthy adults aged 20 to under 60 at consent
2.BMI >=23 and =70 cm^2 at screening
4.Able to enter electronic diaries via PC or smartphone
5.Fully informed of study purpose and procedures, able to consent, and voluntarily agreed in writing
Key exclusion criteria - 1 Currently receiving treatment for any disease with medication or Kampo (as-needed use permitted)
2 Under treatment for obesity, hyperlipidemia, lipid metabolism, or intestinal regulation
3 On physician-supervised diet or exercise therapy
4 Currently dieting or planning to start during study
5 History or presence of serious disease
6 History of gastrointestinal surgery (except appendectomy)
7 Currently taking products affecting obesity, hyperlipidemia, lipid metabolism, including quasi-drugs, FOSHU, functional foods, health foods, or supplements (eligible if discontinued after consent)
8 Currently taking other quasi-drugs, FOSHU, functional foods, health foods, or supplements (eligible if discontinued after consent)
9 Used antibiotics within 1 month before consent or plans to use during study
10 Plans for endoscopy, barium exam, H. pylori eradication, or tooth extraction during study
11 Unable to abstain from alcohol the day before testing
12 History or presence of food or drug allergies
13 >=40 g pure alcohol/day
14 >=21 cigarettes/day
15 Shift workers with night shifts
16 Plans for extended travel or major lifestyle changes during study
17 Tendency toward constipation or diarrhea
18 Unable to discontinue health foods for constipation during study
19 Unable to discontinue probiotics, prebiotics, or supplements containing live bacteria or oligosaccharides during study
20 Currently taking tryptophan supplements (eligible if discontinued after consent)
21 Currently taking protein powders or drinks (eligible if discontinued after consent)
22 Judged by investigator to have impaired renal function
23 Presence of metal implants from surgery
24 Use of pacemaker or implantable medical device
25 Claustrophobia
26 Pregnant, breastfeeding, or planning pregnancy during study
27 Participation in another clinical trial or within 4 weeks after completion, or plans to participate after consent
28 Judged by investigator to be otherwise unsuitable for study
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 24 Day
Date of IRB - 2025 Year 10 Month 28 Day
Anticipated trial start date - 2026 Year 01 Month 10 Day
Last follow-up date - 2026 Year 07 Month 05 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068923
Disclaimer: Curated by HT Syndication.
