Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061916) titled 'The Effects of Low-Carbohydrate Beverage Ingestion on Fluid Retention responses' on June 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Niigata University
Condition:
Condition - NA
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The present study aimed to investigate the effects of sucrose- and isomaltulose-containing beverages at low-to-moderate carbohydrate concentrations (i.e., 1.5%, 4.0%, and 6.5%) on fluid-retention responses in healthy young adults at rest.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Water : Participants consume 1 L of water over 30 min. After ingestion, participants rest in a seated or semi-recumbent position for 3 h. Each trial is separated by at least 7 days. Participants complete the water, sucrose, and isomaltulose trials in a randomized crossover order within each carbohydrate concentration condition; not all participants complete all three carbohydrate concentration conditions.
Interventions/Control_2 - Sucrose-containing beverage: Participants consume 1 L of a sucrose-containing beverage over 30 min. The sucrose concentration is 1.5%, 4.0%, or 6.5%. After ingestion, participants rest in a seated or semi-recumbent position for 3 h. Each trial is separated by at least 7 days. Participants complete the water, sucrose, and isomaltulose trials in a randomized crossover order within each carbohydrate concentration condition; not all participants complete all three carbohydrate concentration conditions.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Young healthy adults
Key exclusion criteria - 1: Smokers and obese individuals
2: Individuals with a history of heart disease
3: Individuals with arrhythmia
4: Individuals with a history of bronchial asthma
5: Individuals with a history of gastrointestinal disorders
6: Individuals with epilepsy
7: Individuals taking medication for chronic conditions or other illnesses
8: Individuals who have previously experienced vagal nerve reflex associated with needle puncture
9: Individuals unable to draw their own blood
10: Individuals deemed ineligible by the principal investigator
Target Size - 36
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 09 Month 01 Day
Date of IRB - 2023 Year 11 Month 06 Day
Anticipated trial start date - 2023 Year 12 Month 01 Day
Last follow-up date - 2024 Year 08 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070842
Disclaimer: Curated by HT Syndication.