- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648580
Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210029
- The First Affiliated Hospital with Nanjing Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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
|
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
give the verbal nutrition education
|
Other: Control group
just give the verbal nutrition education.
|
give the verbal nutrition education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
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.
|
12 weeks
|
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.
|
12 weeks
|
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.
|
12 weeks
|
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.
|
12 weeks
|
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 ".
|
12 weeks
|
Dietary Nutrients
Time Frame: 12 weeks
|
Average daily intake of dietary nutrients
|
12 weeks
|
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. |
12 weeks
|
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.
|
12 weeks
|
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.
|
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JYX201603
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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