Tokyo, Jan. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060312) titled 'The Effects of Foods Containing Plant Extracts on Resting Energy Metabolism
-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 - KSO Corporation
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of foods containing plant extracts on Resting Energy Metabolism
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Foods containing plant extracts, 8 weeks consumption
Interventions/Control_2 - Foods not containing plant extracts, 8 weeks consumption
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Male
Key inclusion criteria - 1) Healthy males aged 30 to 60 years-old.
2) Participants whose BMI is under 30.
3) Participants who have received sufficient explanation about the purpose and content of the examination, have the ability to consent, have a good understanding, volunteered to participate and agreed to participate in the examination in writing.
Key exclusion criteria - Participants (who or who are)
1) with sleep disorders or chronic insomnia.
2) obese, have hyperlipidemia, or are using medications that may affect lipid metabolism.
3) with a history or current condition of thyroid dysfunction.
4) contract, are under treatment for or have a history of serious diseases (e.g., liver, kidney, digestive, heart, respiratory and endocrine diseases, and other metabolic disorders).
5) with a current history of ENT (ear, nose, and throat) conditions, or those unable to breathe through the nose due to other illnesses.
6) under treatment for or have a history of drug addiction and/or alcoholism.
7) whose weight has fluctuated significantly (plus or minus 5kg or more) within the past year.
8) has a routine of intense exercise.
9) have a history and/or a surgical history of digestive disease affecting digestion and absorption.
10) can't stop using supplements and/or functional foods during the study periods.
11) have declared allergic reaction to ingredients of test food.
12) whose lifestyle habits and daily routines vary frequently.
13) on specific dietary restrictions or a diet, such as fasting, extreme low-carb diets, or veganism.
14) can't stop drinking from 2 days before each measurement.
15) have excessive alcohol intake more than approximately 20 g/day of pure alcohol equivalent for four or more days a week.
16) smokers.
17) shift worker or midnight worker.
18) judged as unsuitable for the study as a research participant by the principal investigator during the screening examination.
19) have donated over 200 mL of blood and/or blood components within the last 1 month, or over 400 mL of blood and/or blood components within the last 3 months of obtaining consent.
20) planning to participate and/or had participated in other clinical studies.
21) judged as unsuitable for the current study by the principal investigator for other reasons.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 25 Day
Anticipated trial start date - 2026 Year 01 Month 20 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068981
Disclaimer: Curated by HT Syndication.
