Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000053369) titled 'Clinical study to examine the effects of food ingredient extracts in people with mild cognitive impairment' on Dec. 31.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Tokushima University Graduate School

Condition: Condition - mild cognitive impairment Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether continuous intake of java ginger extract is effective in preventing cognitive decline, improving taste, and preventing infection in mildly cognitively impaired patients, with the primary endpoint of improvement in cognitive function after 6 months of continuous intake, and to compare changes with those before the intervention. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - A pre-intervention survey will be conducted on the subjects, and food extract powder will be continuously consumed twice a day, morning and evening, before, 3 months, and 6 months of intake will be compared. Interventions/Control_2 - A pre-intervention survey will be conducted on the subjects, and placebo will be continuously consumed twice a day, morning and evening, before, 3 months, and 6 months of intake will be compared.

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - Elderly persons who are in good health and have maintained their daily functions but have mild cognitive decline, and who have given consent for the study. Those who have an MMSE score between 24 and 27. Gender: male and female Age: 65 years and older Age: 65 years old or older Organ function: No obvious abnormal values in blood tests Key exclusion criteria - (1) Those suffering from serious cerebrovascular disease, cardiac disease, liver disease, renal disease, gastrointestinal disease, or infectious disease requiring notification (2) Those diagnosed with obvious dementia (3) Those with chronic diseases (diabetes, heart disease, liver failure, renal failure, gastric/duodenal ulcer, colitis, Crohn's disease, cancer, etc.) who are receiving treatment or medication (4) Persons with familial hypercholesterolemia (5) Those with significant abnormalities in blood pressure measurements or blood tests (6) Patients with severe anemia or bleeding tendency (7) Persons with frequent symptoms of diarrhea (8) Persons who may show allergic symptoms to the test sample (9) Patients who are regular users of excessive smoking and alcohol, and those who have extremely irregular lifestyles in terms of diet, sleep, etc. (10)Persons who are currently participating or have participated within one month in other clinical trials. (11)Other subjects who are judged to be ineligible by the study sponsor.

Translated with www.DeepL.com/Translator (free version) Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2023 Year 01 Month 15 Day Anticipated trial start date - 2024 Year 01 Month 15 Day Last follow-up date - 2026 Year 01 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060910

Disclaimer: Curated by HT Syndication.