Tokyo, Feb. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060621) titled 'Effects of Mushroom Intake on the Profile of Blood Lipoprotein Subclasses' on Feb. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Kagawa Nutrition University
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of consuming test food (mushrooms) on the profile of blood lipoprotein subclasses
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Consume 50g of the test food (mushrooms) daily for two weeks.
Interventions/Control_2 - Consume 50g of the test food (mushrooms) daily for two weeks.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - Women aged 18 years or older. Individuals classified as physical activity levels I or II.
Key exclusion criteria - Individuals with a history or current condition of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
Individuals who have habitually taken medication for the treatment of illness within the past month (excluding occasional use for headaches, menstrual pain, colds, etc.).
Individuals with a history or current condition of severe impairment of the liver, kidneys, heart, lungs, blood, etc.
Individuals with concomitant diseases or a history of severe conditions involving the digestive organs.
Individuals currently suffering from a disease and receiving drug therapy.
Individuals who have undergone surgery due to illness or injury (within 2 months prior to study start).
Individuals whose weight fluctuated by more than 2 kg (within 3 months of the trial start date).
Individuals who donated blood exceeding 200 mL within 1 month prior to the start of this trial, or 400 mL within 3 months prior.
Individuals who have previously experienced discomfort or worsening health following blood collection.
Individuals with food allergy symptoms, or those at risk of developing them.
Smokers.
Regular alcohol drinkers.
Individuals who routinely engage in strenuous exercise.
Individuals whose lifestyle habits may change during the study period (e.g., extended travel).
Individuals who are currently taking, or have taken within the past 3 months, health functional foods on a continuous basis, or who plan to take them during the study period.
Individuals who do not agree with the purpose of the study as explained during the pre-study briefing.
Pregnant, breastfeeding, or potentially pregnant individuals.
Individuals currently participating in another human clinical trial or those who have completed participation within the last 3 months.
Other individuals deemed unsuitable for this trial by the responsible physician.
Target Size - 45
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 10 Month 16 Day
Date of IRB - 2025 Year 10 Month 16 Day
Anticipated trial start date - 2026 Year 02 Month 07 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069308
Disclaimer: Curated by HT Syndication.