Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062808) titled 'Effect of Reducing Inorganic Phosphate from Food Additives on Urinary Phosphate Excretion' on Sept. 4.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Tokyo University of Agriculture
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to investigate the effect of reducing inorganic phosphate intake from food additives on 24-hour urinary phosphate excretion in healthy adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention 1: Control condition
Participants consume the control experimental diet containing the usual amount of inorganic phosphate derived from food additives for one day.
Interventions/Control_2 - Intervention 2: P-250 condition
Participants consume an experimental diet containing 250 mg less inorganic phosphate derived from food additives than the control diet for one day.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Healthy adults aged 18 years or older.
2. Individuals who have received a sufficient explanation of the study and provided written informed consent voluntarily.
3. Individuals who are able to comply with the study procedures, including consumption of the provided experimental diets and 24-hour urine collection.
Key exclusion criteria - 1. Individuals with kidney disease, cardiovascular disease, diabetes mellitus, or other diseases that may affect participation in the study.
2. Individuals who regularly use medications or supplements that may affect phosphate, calcium, or sodium metabolism.
3. Individuals with allergies to any foods included in the experimental diets.
4. Individuals who are pregnant or breastfeeding.
5. Individuals judged by the investigators to be unsuitable for participation in the study.
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 08 Month 25 Day
Date of IRB - 2026 Year 08 Month 25 Day
Anticipated trial start date - 2026 Year 09 Month 04 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071905
Disclaimer: Curated by HT Syndication.