Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062755) titled 'The Effects of the Medicinal-Food Homology Coix Seed Coarse Grains Beverage supplementation on Chronic Low-grade Systemic Inflammation in overweight or obese Individuals' on Aug. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - School of Public Health of Tianjin University of Traditional Chinese Medicine
Condition:
Condition - Chronic Low-grade Systemic Inflammation
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - To evaluate the effects of a medicinal-food homology Coix Seed Coarse Grains Beverage on chronic low-grade systemic inflammation in overweight and obese individuals.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - intervention group: Coix Seed Coarse Grains Beverage Group: 20 g per sachet, orally once daily with warm water for 60 days + restricted calorie diet
Interventions/Control_2 - control group: restricted calorie diet
Eligibility:
Age-lower limit - 35
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Adults aged 35-65 years, regardless of sex;
2.Overweight or obesity with a body mass index of 24.0-35.0 kg/m^2;
3.Abnormal chronic low-grade systemic inflammation-related biomarkers, such as an elevated serum high-sensitivity C-reactive protein level above the normal reference range(typically 1.0-3.0 mg/L).
Key exclusion criteria - 1.History of allergy or related conditions;
2.Diagnosed autoimmune diseases, severe cardiovascular or cerebrovascular diseases, cancer, hepatic or renal dysfunction, etc.;
3.Use of anti-inflammatory drugs, antibiotics, or weight-loss drugs within 3 months before study initiation;
4.Long-term use of anti-inflammatory supplements, such as fish oil or curcumin;
5.Pregnancy, lactation, or plans for pregnancy;
6.Cognitive impairment or inability to communicate adequately;
7.Surgery or acute/chronic inflammation within the previous 3 months that may affect outcome assessment;
8.Planned relocation, travel, or other circumstances that may prevent completion of follow-up.
Target Size - 30
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 04 Month 14 Day
Date of IRB - 2026 Year 08 Month 06 Day
Anticipated trial start date - 2026 Year 04 Month 15 Day
Last follow-up date - 2026 Year 11 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071851
Disclaimer: Curated by HT Syndication.
