Clinical Trial: Nutritional improvement trial to reduce early undernutrition risk in healthy older adults (pilot): a four-arm randomized controlled trial comparing add-on nutritional supplementation or nutrition counseling within a community-based multimodal program (Japan)

Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061009) titled 'Community-based multimodal program with nutritional support to improve early undernutrition risk in healthy older adults: pilot trial' on March 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kagawa Nutrition University

Condition: Condition - Early undernutrition risk Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To pilot-test and compare the effects of three add-on nutritional support options (balanced ONS, protein-fortified beverage, or nutrition counseling) within a community-based multimodal program on early undernutrition risk (EUNS) and related outcomes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Arm A: Balanced oral nutritional supplement (125 mL twice/day; 400 kcal/day; 15 g protein/day) Interventions/Control_2 - Arm B: Protein-fortified beverage (200 mL once/day; 15 g protein/day)

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - 1) Older adults living in the target community 2) Able to participate in group sessions and home-based activities/self-monitoring 3) Provided written informed consent Key exclusion criteria - 1) Individuals with blood pressure or pulse significantly deviating from normal ranges (e.g., resting systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg, resting pulse rate >=110 beats/min or <=50 beats/min, etc.), or showing marked differences from usual levels 2) Individuals with severe heart disease, kidney disease, liver disease, respiratory disease, circulatory disease, musculoskeletal disease, or other progressive chronic conditions or symptoms 3) Individuals exhibiting significant cognitive decline 4) Individuals with food allergies or lactose intolerance symptoms (frequent abdominal pain or diarrhea after consuming dairy products) 5) Individuals requiring protein intake restriction 6) Individuals who participated in any other clinical trial within the 3 months prior to the study, including the present trial Target Size - 100

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2020 Year 08 Month 01 Day Date of IRB - 2020 Year 09 Month 02 Day Anticipated trial start date - 2020 Year 09 Month 16 Day Last follow-up date - 2021 Year 06 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069634

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