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Completed

NCT Number: NCT03648580

Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass

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.

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Key information

Conditions

Malnutrition Risk in Elder

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the one who is or is between 65 to 85 years old, male or female;
  • the one with nutritional risk according to MNA-Short Form evaluation (score less than12);
  • 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

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

Treatment and study plan

Ensure Complete powder

Dietary Supplement

Supply the Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks

verbal nutrition education

Other

give the verbal nutrition education

Primary outcomes

  1. Mini Nutritional Assessment short-form (MNA®-SF) score

    Time frame: 12 weeks

    MNA®-SF is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The Screening score(max. 14 points) is 12-14 points indicates "Normal nutritional status", 8-11 points indicates "At risk of malnutrition", 0-7 points indicates "Malnourished".

Secondary outcomes

  1. Muscle mass--The change of percentage of skeletal muscle mass

    Time frame: 12 weeks

    The skeletal muscle mass of the participants were assessed using a multiple-frequency bioelectrical impedance analysis (BIA) instrument (InBodyS10; InBody, Shanghai, China). Percentage of skeletal muscle mass (PSM) is the ratio of skeletal muscle mass to ideal skeletal muscle mass which is defined according to the height and the standard BMI of each patient. Normal PSM standard is defined as values in the range of 90-110%. We defined low skeletal muscle mass (Sarcopenia) as values <90% of the standard.

  2. The change of BMI

    Time frame: 12 weeks

    Weight in kilograms was measured during the study. Height in meters was measured at the baseline. Weight and height will be combined to report BMI in kg/m^2.

  3. Muscle strength--The change of Calf circumference

    Time frame: 12 weeks

    Calf circumference(CCF) was measured with a soft tape, the measurement standard is divided into less than 31 cm and 31 cm or greater.

  4. Muscle strength--The change of Grip strength

    Time frame: 12 weeks

    Grip strength with a calibrated grip force meter to measure the grip strength of the dominant hand. The cut-off of grip strength is 26 kg for men and 18 kg for women.

  5. Muscle strength--6 meters gait speed

    Time frame: 12 weeks

    A standard stopwatch is used to measure the subject's 6 meters gait speed for 3 times, and the average pace is then calculated. The intercept value of step speed is 0.8m/s.

  6. Hidden Hunger Assessment Scale

    Time frame: 12 weeks

    There are two parts in Hidden Hunger Assessment Scale. Part A includes the options for 10 dietary behaviors, giving 3 behavioral frequency choices (> 3 times per week, 5 points; 1 to 3 times per week, 3 points; never, 0 points), score ranges from 0 to 50 which are evaluated and classified into three categories. Part B includes 17 options on the manifestation of micronutrient deficiencies, giving three frequencies of occurrence to score (consecutive, 0 points; occasionally, 3 points; never, 5 points). The result ranges from 0 to 85, while different ranges were evaluated and defined differently. The scores of Part A and B of the participants were summed up and separated into three definition: <70 as "obvious hunger requesting immediate intervention", 70-123 as "existing hidden hunger requesting improvement", and > 123 as "no hidden hunger ".

  7. Dietary Nutrients

    Time frame: 12 weeks

    Average daily intake of dietary nutrients

  8. The change of DETERMINE score

    Time frame: 12 weeks

    The DETERMINE is checklist to find out if someone you know is at nutritional risk. The checklist is based on warning signs described. DETERMINE is the first letter of all warning signs: Disease, Eating poorly, Tooth loss/month pain, Economic hardship, Reduced social contact, Multiple medicines, Involuntary weight loss/gain, Needs assistance in self care, Elder years above age 80.

    The total score is 21. 0-2 scores means good, recheck your nutritional scores in 6 months.

    3-5 scores you are at moderate nutrition risk. Recheck your nutritional scores in 3 months.

    6 or more scores means you are at high nutrition risk. Bring this checklist the next time you see your doctor, dietitian or other qualified health or social service professional. Talk with them about any problem you may have. Ask for help to improve your nutritional health.

  9. Questionnaire--Healthy lifestyle questionnaire

    Time frame: 12 weeks

    Healthy lifestyle questionnaire be designed by investigator. 24 questions cover healthy lifestyle, that are about disease, fallen, infection, allergy, drink alcohol, smoke, eating habit, activity intensity/frequency, sleep quality, emotion etc.

  10. Questionnaire--Self-satisfaction questionnaire

    Time frame: 12 weeks

    The self-satisfaction questionnaire be completed by subject. The questionnaires be used to evaluate self-rate satisfaction for stool pattern, sleep, health status, quality of life, energy level, vitality level, daily activities. There are some questions to get the state of the stool pattern and sleep. Others are evaluated in the percentage.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 27, 2018
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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