Malnutrition , At-risk for malnutrition in the elderly. malnutrition oral nutritional supplement randomized controlled trial tapioca starch weight loss
Conditions
Interventions
Participants in this group will get a medical food product made for this study. It'
s a powder supplement with modified tapioca starch, soy and egg white proteins, vitamins, and minerals. Each serving provides 200 to 300 kcal of energy and 8 to 12 grams of protein. Participants will
ll be asked to have at least two servings a day and will also get the same nutritional counseling.
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
medical food,placebo
Sponsors
Agricultural Research Development Agency
Baanpong Tapioca Flour Industrial Co., Ltd.)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 Men or women aged 60 years or older. 2 Ambulatory. 3 MNA score indicating risk of malnutrition (17-23.5) or malnutrition (less than 17). 4 Able to consume food and drink orally, communicate, and follow instructions. 5 Living in the community or being discharged from the hospital, not in a long-term care facility.
Exclusion criteria
Exclusion criteria: 1 Allergy or intolerance to milk products or any component in the study product. 2 Uncontrolled hypertensive crisis. 3 Diagnosis of diabetes on glucose-lowering medication or HbA1c greater than 7%. 4 Active cancer or treatment for cancer within the past 6 months (exceptions apply). 5 Renal impairment (eGFR less than 30 mL/min/1.73 m2). 6 Presence of a pacemaker or defibrillator, or implanted metal that prevents Bioelectrical Impedance Analysis (BIA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight day 90 Increase in body weight (kg) from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital admission-free survival within 90 days 90 day Count, %,Lab values including fasting plasma glucose, Blood Urea Nitrogen, Creatinine, Aspartate Aminotransferase, Alanine Aminotransferase, Albumin, and Prealbumin 90 day Lab measurement,Body Mass Index, mid-upper arm circumference, and calf circumference 90 day anthropometry,Body composition (by Bioelectrical Impedance Analysis) 90 day BIA,Functional status (Handgrip strength, handgrip endurance, Short Physical Performance Battery, and Modified Barthel Index) 90 day Performance testing,Nutritional scores (Mini Nutritional Assessment and the Nutrition Alert Form) 90 day questionnaire,Quality of life (SF-36 questionnaire) 90 day questionnaire | — |
Countries
Thailand
Contacts
Public ContactPornpoj Pramyothin
Mahidol University
Outcome results
None listed