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

Primary Purpose

Malnutrition Risk in Elder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ensure Complete powder
verbal nutrition education
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition Risk in Elder

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

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

just give the verbal nutrition education.

Outcomes

Primary Outcome Measures

Mini Nutritional Assessment short-form (MNA®-SF) score
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 Outcome Measures

Muscle mass--The change of percentage of skeletal muscle mass
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.
The change of BMI
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.
Muscle strength--The change of Calf circumference
Calf circumference(CCF) was measured with a soft tape, the measurement standard is divided into less than 31 cm and 31 cm or greater.
Muscle strength--The change of Grip strength
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.
Muscle strength--6 meters gait speed
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.
Hidden Hunger Assessment Scale
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 ".
Dietary Nutrients
Average daily intake of dietary nutrients
The change of DETERMINE score
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.
Questionnaire--Healthy lifestyle questionnaire
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.
Questionnaire--Self-satisfaction questionnaire
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.

Full Information

First Posted
December 20, 2017
Last Updated
December 13, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03648580
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition Risk in Elder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the subjects will be randomized into intervention group and control group.
Masking
None (Open Label)
Masking Description
It's an open study. The number of protocol evaluable subjects for each group that complete the study and comply well with study protocol is planned to be 30.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Give the verbal nutrition education and supply Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks
Arm Title
Control group
Arm Type
Other
Arm Description
just give the verbal nutrition education.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure Complete powder
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
verbal nutrition education
Intervention Description
give the verbal nutrition education
Primary Outcome Measure Information:
Title
Mini Nutritional Assessment short-form (MNA®-SF) score
Description
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".
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Muscle mass--The change of percentage of skeletal muscle mass
Description
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.
Time Frame
12 weeks
Title
The change of BMI
Description
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.
Time Frame
12 weeks
Title
Muscle strength--The change of Calf circumference
Description
Calf circumference(CCF) was measured with a soft tape, the measurement standard is divided into less than 31 cm and 31 cm or greater.
Time Frame
12 weeks
Title
Muscle strength--The change of Grip strength
Description
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.
Time Frame
12 weeks
Title
Muscle strength--6 meters gait speed
Description
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.
Time Frame
12 weeks
Title
Hidden Hunger Assessment Scale
Description
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 ".
Time Frame
12 weeks
Title
Dietary Nutrients
Description
Average daily intake of dietary nutrients
Time Frame
12 weeks
Title
The change of DETERMINE score
Description
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.
Time Frame
12 weeks
Title
Questionnaire--Healthy lifestyle questionnaire
Description
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.
Time Frame
12 weeks
Title
Questionnaire--Self-satisfaction questionnaire
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting Zhao
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

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

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