Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060871) titled 'Effects of Vinegar on Absorption of Minerals (Ca, Mg)' on May 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Mizkan Holdings Co., Ltd.
Condition:
Condition - Healthy Adult Males
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of vinegar on the absorption of minerals (Ca, Mg) in foods pickled in vinegar
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake the "vinegar-containing food" and "salted rice balls" for breakfast. Drinking water and lunch are to be provided. (The vinegar-containing food are prepared by mixing 22.5 mL of grain vinegar and 10 g of sugar, placing 12 g of dried sardines in a plastic bag so that the entire contents were submerged, and refrigerating overnight. The following morning, the entire contents are removed, 4.9 g of freeze-dried grated daikon radish, and 15 mL of water are added, and the mixture is mixed thoroughly.)
Washout for 2 weeks
Intake the "vinegar-free food" and "salted rice balls" for breakfast. Drinking water and lunch are to be provided. (The vinegar-free food are prepared by mixing 22.5 mL of water and 10 g of sugar, placing 12 g of dried sardines in a plastic bag so that the entire contents were submerged, and refrigerating overnight. The following morning, the entire contents are removed, 4.9 g of freeze-dried grated daikon radish, and 15 mL of water are added, and the mixture is mixed thoroughly.)
Interventions/Control_2 - Intake the "vinegar-free food" and "salted rice balls" for breakfast. Drinking water and lunch are to be provided. (The vinegar-free food are prepared by mixing 22.5 mL of water and 10 g of sugar, placing 12 g of dried sardines in a plastic bag so that the entire contents were submerged, and refrigerating overnight. The following morning, the entire contents are removed, 4.9 g of freeze-dried grated daikon radish, and 15 mL of water are added, and the mixture is mixed thoroughly.)
Washout for 2 weeks
Intake the "vinegar-containing food" and "salted rice balls" for breakfast. Drinking water and lunch are to be provided. (The vinegar-containing food are prepared by mixing 22.5 mL of grain vinegar and 10 g of sugar, placing 12 g of dried sardines in a plastic bag so that the entire contents were submerged, and refrigerating overnight. The following morning, the entire contents are removed, 4.9 g of freeze-dried grated daikon radish, and 15 mL of water are added, and the mixture is mixed thoroughly.)
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - (1) Healthy male between 20 and 65 years old
(2) Subjects who can agree to participate in this study
(3) Subjects who can come to the designated room on the designated date and time, and can collect urine, eat, and drink
Key exclusion criteria - (1) Subjects currently suffer from some chronic disease and are receiving drug treatment
(2) Subjects with renal dysfunction
(3) Subjects who regularly use magnesium oxide as a laxative
(4) Subjects having possibilities for emerging allergy for foods
(5) Subjects taking daily mineral medications or supplements
(6) Subjects who drink much alcohol
Target Size - 14
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 10 Month 12 Day
Date of IRB - 2025 Year 10 Month 16 Day
Anticipated trial start date - 2025 Year 12 Month 04 Day
Last follow-up date - 2026 Year 01 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069657
Disclaimer: Curated by HT Syndication.