Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060741) titled 'Measurement of the Glycemic Index of Pasta Containing Glucomannan' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Otsuma Women's University, Faculty of Home Economics, Department of Food Science
Condition:
Condition - Healthy adults with normal food habit
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify whether pasta containing glucomannan lowers the GI and suppresses blood sugar spikes in healthy individuals.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Commercial pasta
Interventions/Control_2 - Pasta with glucomannan
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Participants who voluntarily express their intent to join the trial and meet the following criteria:
(1) Adult men and women aged 20 years or older but under 50 years at the time of consent acquisition
(2) Individuals with a BMI of 30 or below
(3) Individuals who have received prior explanation of the clinical trial, understand the content including informed consent in accordance with the Declaration of Helsinki, agree with its purpose, and can provide written consent themselves
Key exclusion criteria - (1) Individuals taking diabetes medication
(2) Individuals receiving insulin therapy
(3) Individuals with wheat allergies
(4) Individuals with a history of digestive tract surgery that affects digestion and absorption
(5) Individuals who are pregnant, may be pregnant, or are breastfeeding
(6) Individuals who regularly consume dietary fiber supplements (products containing dietary fiber derived from seaweed, konjac, psyllium, etc.) or whole grains (including whole wheat, brown rice, rye, barley, etc.)
(7) Individuals currently participating in other drug or health supplement clinical trials, those within 4 weeks of completing such a trial, or those planning to participate in another clinical trial after giving consent for this trial
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 20 Day
Date of IRB - 2026 Year 01 Month 15 Day
Anticipated trial start date - 2026 Year 02 Month 28 Day
Last follow-up date - 2026 Year 07 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069500
Disclaimer: Curated by HT Syndication.