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Clinical Trials/NCT03648580
NCT03648580
Completed
Not Applicable

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

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country78 target enrollmentMay 20, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition Risk in Elder
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
78
Locations
1
Primary Endpoint
Mini Nutritional Assessment short-form (MNA®-SF) score
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2017
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ting Zhao

Technologist-in-charge

The First Affiliated Hospital with Nanjing Medical University

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

Outcomes

Primary Outcomes

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

  • Muscle mass--The change of percentage of skeletal muscle mass(12 weeks)
  • Muscle strength--The change of Calf circumference(12 weeks)
  • Dietary Nutrients(12 weeks)
  • The change of DETERMINE score(12 weeks)
  • The change of BMI(12 weeks)
  • Muscle strength--6 meters gait speed(12 weeks)
  • Questionnaire--Healthy lifestyle questionnaire(12 weeks)
  • Questionnaire--Self-satisfaction questionnaire(12 weeks)
  • Muscle strength--The change of Grip strength(12 weeks)
  • Hidden Hunger Assessment Scale(12 weeks)

Study Sites (1)

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