Malnutrition Risk in ElderNCT03648580
Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
A study testing Ensure Complete powder and verbal nutrition education in people with Malnutrition Risk in Elder, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Malnutrition Risk in Elder
- What is being tested?
- Ensure Complete powder and verbal nutrition education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing
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.
- Conditions
- Malnutrition Risk in Elder
- Being tested
- Ensure Complete powder, verbal nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure Complete powderDietary 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 educationOther
give the verbal nutrition education
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Dietary Supplement: Ensure Complete powder; Other: verbal nutrition education |
| Control group | Other | just give the verbal nutrition education. Receives: Other: verbal nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 12 weeks
Secondary outcomes (10)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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 ".
Measured: 12 weeks
Dietary Nutrients
Average daily intake of dietary nutrients
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start20 May 2017
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition Risk in ElderStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the subjects will be randomized into intervention group and control group.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Zhao, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Ting Zhao, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648580
- Sponsor's protocol ID
- JYX201603
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2017
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing
- ClinicalTrials.gov ID
- NCT03648580
- Acronym / sponsor ID
- JYX201603
- Conditions
- Malnutrition Risk in Elder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the subjects will be randomized into intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Ensure Complete powder, Other: verbal nutrition educationGive 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 |
| Control group | Other | Other: verbal nutrition educationjust give the verbal nutrition education. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure Complete powderSupply 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 | Dietary supplement | Intervention group |
| verbal nutrition educationgive the verbal nutrition education | Other | Control group, Intervention group |
Primary outcome
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".
10 secondary outcomes
Muscle mass--The change of percentage of skeletal muscle mass
Time frame: 12 weeks
The change of BMI
Time frame: 12 weeks
Muscle strength--The change of Calf circumference
Time frame: 12 weeks
Muscle strength--The change of Grip strength
Time frame: 12 weeks
Muscle strength--6 meters gait speed
Time frame: 12 weeks
Hidden Hunger Assessment Scale
Time frame: 12 weeks
Dietary Nutrients
Time frame: 12 weeks
The change of DETERMINE score
Time frame: 12 weeks
Questionnaire--Healthy lifestyle questionnaire
Time frame: 12 weeks
Questionnaire--Self-satisfaction questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Zhao principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Complete powder and verbal nutrition education in people with Malnutrition Risk in Elder, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Nutritional Assessment short-form (MNA®-SF) score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.