Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056403) titled 'The Effect of Coffee-derived Mannooligosaccharides on Calcium Absorption in Healthy Adults
-A Systematic Review with Meta-analysis-:Protocol' on Oct. 1.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - Ajinomoto AGF, INC.
Condition:
Condition - The subjects are healthy volunteers (excluding those under 20, pregnant women, and lactating women, who were not suffering from any diseases).
Studies that are relevant to the outcome in question and include participants being treated as patients will be excluded.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study was to determine whether the intake of foods containing 'coffee bean-derived mannooligosaccharides' has the ability to promote the absorption of calcium in the diet in healthy adults, specifically from the urinary calcium content (creatinine corrected) (mg/g Cr) at each intake time.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - P-Participant:The subjects are healthy volunteers (excluding those under 20, pregnant women, and lactating women, who were not suffering from any diseases).
Studies that are relevant to the outcome in question and include participants being treated as patients will be excluded.
I-Intervention:The intervention condition is oral intake of a test product containing at least 0.5 g of 'coffee bean-derived mannooligosaccharides' (any form of intake).
C-Comparison:A comparison was made among one receiving a placebo, another serving as a control group in which food was substituted with food that does not contain 'coffee-derived mannooligosaccharides' and group with no intervention.
O-Outcome measurement:
Primary outcomes:The primary outcome is the effect of promoting intestinal absorption of calcium.Specifically, the urinary calcium content (creatinine corrected) (mg/g Cr) at each hour of intake will be the primary endpoint.
S-Study design:The research designs used in the literature were randomized parallel group controlled trials, quasi-randomized controlled trials, non-randomized controlled trials, and crossover studies. In addition, the languages of presentation were documents written in Japanese and English. In principle, the form of presentation should be an original paper, but short reports and reports may be accepted if the content can be identified. To avoid publication bias, studies that include results published in clinical trial registration databases are also eligible. For the time period, studies published from the first time the databases were opened or loaded to the date of the search will be included in the search.
Key exclusion criteria - Abstracts of conference presentations (conference proceedings) will be excluded they are considered insufficiently descriptive. Other gray documents will be excluded it is difficult to confirm their appropriateness.
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 12 Month 04 Day
Anticipated trial start date - 2024 Year 12 Month 16 Day
Last follow-up date - 2025 Year 04 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064390
Disclaimer: Curated by HT Syndication.