Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062919) titled 'Preliminary Investigation of the Effects of a Calcium-Fortified Breakfast on Glucose Tolerance and Lipid Metabolism Indicators (TG/HDL Ratio) in Japanese Adults' on Sept. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Aikoku Gakuen Junior College
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate, through a randomized parallel-group comparative trial, the effects of continued consumption of calcium-fortified granola and milk as breakfast on glycemic indicators (fasting blood glucose and HbA1c) and lipid metabolism indicators (TG, LDL-C, HDL-C, and the TG/HDL ratio) in healthy Japanese adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Eat Consuming Calcium Fortified Granola at breakfast
Interventions/Control_2 - Eat Granola at breakfast
Eligibility:
Age-lower limit - 19
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Healthy Japanese adults
2. Age: 19 to 65 years
3. BMI: 20 to 30 kg/m2
4. Individuals who skip breakfast or consume only about 100 kcal for breakfast. 5. Individuals who fully understand the study procedures and provide written informed consent
Key exclusion criteria - 1. Individuals currently receiving treatment for lifestyle-related diseases, such as diabetes mellitus, dyslipidemia, or hypertension
2. Individuals who regularly use calcium preparations, supplements, or similar products
3. Individuals with allergies to dairy products, wheat, or any ingredients contained in granola
4. Individuals with skin conditions, eczema, or similar conditions at the sensor application site (the back of the upper arm), or those with severe allergies to adhesives such as those used in adhesive bandages
5. Pregnant or breastfeeding individuals
6. Individuals deemed unsuitable for participation by the principal investigator or the study physician
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 01 Day
Anticipated trial start date - 2026 Year 09 Month 16 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072037
Disclaimer: Curated by HT Syndication.