Clinical trial NCT03648580: Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
Official title: Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition Risk in Elder
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the subjects will be randomized into intervention group and control group.
Primary purpose: TREATMENT

Brief summary: Background: As the aging of the population aggravating, the ratio of the elderly in empty nest family has reached 50%, particularly in big and medium size cities, it is as high as 70%. The elderly in those families where no child living inside, elderly living alone, including an individual living alone or living with spouse are known as empty nester. The diversity of food consumption of empty nester is always poor, with single and simple meals, especially for the consumption of "core food" (fish, meat, egg, milk, vegetables and fruits), and the quantity and variety of consumption is very limited, which make the elderly be prone to be deficient of high quality protein and micronutrient. In 2005, the World Health Organization (WHO) brought up a new concept for the universally exiting problem of vitamin and trace elements intake deficiency among people, namely Hidden Hunger. With age increasing, multiple causes such as single eating pattern, empty nest lifestyle and chronic diseases lead to long term intake deficiency of protein and micronutrient of the elderly, which will further result in various symptoms of nutritional deficiency. Therefore, it is particularly important for the empty nester to have sufficient energy, high quality protein and multiple micronutrients to prevent hidden hunger and sarcopenia, thus avoiding the health problem and life quality decreasing caused by them.


Eligibility criteria: Inclusion Criteria:

1. the one who is or is between 65 to 85 years old, male or female;
2. the one with nutritional risk according to MNA-Short Form evaluation (score less than12);
3. the one who has low skeletal muscle mass (with bioelectrical impedance analysis report indicating that the skeletal muscle mass is less than 90% of the normal level) and/or the one who has at least 1 type of the micronutrient deficiency symptom (part A \< 40 or part A \< 85 in the hidden hungry evaluation questionnaire)

Exclusion Criteria:

1. long-term bedridden or the one has difficult in taking food orally;
2. Liver failure in recent one year;
3. Renal insufficiency (serum creatinine is more than 2 times of normal value)
4. the one who is allergic to or not applicable to the component in oral dietary supplement;
5. the one with parkinsonism, epilepsy and other nervous system disorders;
6. malignant tumor patients with chemotherapy and chemotherapy;
7. irritable bowel disease and other chronic wasting diseases.
8. Taking multi-vitamin\&mineral supplements or protein or other oral nutritional supplements

Primary outcomes:
measure: Mini Nutritional Assessment short-form (MNA®-SF) score
timeFrame: 12 weeks
Secondary outcomes:
measure: Muscle mass--The change of percentage of skeletal muscle mass
timeFrame: 12 weeks
measure: The change of BMI
timeFrame: 12 weeks
measure: Muscle strength--The change of Calf circumference
timeFrame: 12 weeks
measure: Muscle strength--The change of Grip strength
timeFrame: 12 weeks
measure: Muscle strength--6 meters gait speed
timeFrame: 12 weeks
measure: Hidden Hunger Assessment Scale
timeFrame: 12 weeks
measure: Dietary Nutrients
timeFrame: 12 weeks
measure: The change of DETERMINE score
timeFrame: 12 weeks
measure: Questionnaire--Healthy lifestyle questionnaire
timeFrame: 12 weeks
measure: Questionnaire--Self-satisfaction questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Ting Zhao
role: PRINCIPAL_INVESTIGATOR
References: