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

13 dicembre 2019 aggiornato da: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

78

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210029
        • The First Affiliated Hospital with Nanjing Medical University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 65 anni a 85 anni (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Integratore alimentare: Ensure Complete powder
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
Altro: verbal nutrition education
give the verbal nutrition education
Altro: Control group
just give the verbal nutrition education.
Altro: verbal nutrition education
give the verbal nutrition education

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mini Nutritional Assessment short-form (MNA®-SF) score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Muscle mass--The change of percentage of skeletal muscle mass
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 weeks
Average daily intake of dietary nutrients
12 weeks
The change of DETERMINE score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigatori

  • Investigatore principale: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 maggio 2017

Completamento primario (Effettivo)

31 dicembre 2018

Completamento dello studio (Effettivo)

30 giugno 2019

Date di iscrizione allo studio

Primo inviato

20 dicembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

23 agosto 2018

Primo Inserito (Effettivo)

27 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 dicembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 dicembre 2019

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • JYX201603

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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