Tokyo, Sept. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062793) titled 'Effects of Cumin Intake on Body Composition and Lipid Metabolism: An Exploratory Randomized Controlled Trial Focusing on Sex Differences' on Sept. 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - The Jikei University School of Medicine
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of cumin intake on body composition, lipid metabolism, and glycation markers in healthy adults compared with placebo, and to explore potential sex differences in these effects.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Participants will take one soft capsule containing essential oil extracted from cumin (equivalent to 3.0-4.0 g of cumin powder) once daily for 12 weeks. No specific timing of intake will be required, and participants will be instructed to maintain their usual dietary and exercise habits throughout the study.
Interventions/Control_2 - Participants will take one placebo soft capsule containing no cumin once daily for 12 weeks. No specific timing of intake will be required, and participants will be instructed to maintain their usual dietary and exercise habits throughout the study.
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy men and women aged 30 years or older and younger than 65 years.
2. Individuals with a body mass index (BMI) of 22 kg/m2 or higher and 30 kg/m2 or lower.
3. Individuals who have received sufficient information about the study and provided voluntary informed consent to participate.
Key exclusion criteria - 1. Individuals younger than 30 years or aged 65 years or older.
2. Individuals with a BMI lower than 22 kg/m2 or higher than 30 kg/m2.
3. Individuals who have newly initiated a diet, exercise program, or supplement use for weight loss within 3 months before the start of the study.
4. Individuals currently using medications that may affect body weight, fat mass, glucose metabolism, or lipid metabolism, including antidiabetic drugs, anti-obesity drugs, corticosteroids, and GLP-1 receptor agonists.
5. Individuals with serious underlying diseases, including severe liver, kidney, or heart disease, malignancy, active infection, or autoimmune disease, considered inappropriate for participation by the investigator.
6. Women who are pregnant, breastfeeding, or may be pregnant.
7. Individuals unable to avoid daily consumption of foods containing curry powder during the study period.
8. Individuals with a history of allergy to cumin or any component of the study product, including gelatin.
9. Individuals considered unable to continue consuming the study product because of gastrointestinal symptoms or gastrointestinal diseases.
10. Individuals for whom InBody measurements cannot be appropriately performed, such as those with a cardiac pacemaker.
11. Individuals currently participating or planning to participate in another interventional study during the study period.
12. Individuals considered inappropriate for participation by the principal investigator or other investigators.
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 08 Month 03 Day
Date of IRB - 2026 Year 08 Month 03 Day
Anticipated trial start date - 2026 Year 08 Month 10 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071878
Disclaimer: Curated by HT Syndication.
