Tokyo, Sept. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062951) titled 'Effects of snack modification on post-dinner blood glucose: An intervention study' on Sept. 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - University of Shizuoka
Condition:
Condition - healthy subject
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We previously found that skipping lunch worsened the glycemic response after dinner and was accompanied by lower circulating bile acid and GLP-1 concentrations.
We therefore hypothesized that consuming snacks containing nutrients such as fat and protein, which may stimulate bile acid-related signaling and GLP-1 secretion, could attenuate the worsening of the post-dinner glycemic response induced by lunch skipping.
Accordingly, this study aims to determine whether snacks with different nutrient compositions consumed after skipping lunch can attenuate the worsening of the post-dinner glycemic response.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - On the first day, participants undergo anthropometric measurements and body composition assessment and complete a self-administered questionnaire. Participants wear an intermittently scanned continuous glucose monitoring (isCGM) device on the upper arm for 10 days from the first day of the study.
During the study period, meal times are fixed at 7:00 for breakfast, 12:00 for lunch, 15:00 for a snack, and 18:00 for dinner. Participants are allowed to consume only water or non-sugar tea as beverages, and all meals are provided by the researchers. Participants record the time of each meal throughout the intervention period.
On days 3, 5, 7, and 9, participants undergo the randomized intervention conditions.
Intervention 1: Lunch consumption (control)
Interventions/Control_2 - Lunch skipping
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Men and women aged 18 years or older with a BMI of 18.5 or more and less than 25 kg/m2 and no personal history of diabetes or family history of diabetes in first- or second-degree relatives.
Key exclusion criteria - 1) Pregnant or lactating women
2) Current smokers
3) Individuals who habitually skip meals
4) Individuals with food allergies, including a history of allergy to any of the 29 specified allergenic foods, flaxseed oil, or similar products
5) Individuals taking medications for diabetes, dyslipidemia, hypertension, or hyperuricemia
6) Individuals deemed unsuitable for participation in the study by the principal investigator
Target Size - 14
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 17 Day
Date of IRB - 2026 Year 08 Month 17 Day
Anticipated trial start date - 2026 Year 09 Month 16 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=R000072071
Disclaimer: Curated by HT Syndication.