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

NCT03648580 | Completed

• 1 other identifier: JYX201603
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition Risk in Elder

Outcome Measures

Primary Outcomes (1)

• 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".

  12 weeks

Secondary Outcomes (10)

• Muscle mass--The change of percentage of skeletal muscle mass

  12 weeks

• The change of BMI

  12 weeks

• Muscle strength--The change of Calf circumference

  12 weeks

• Muscle strength--The change of Grip strength

  12 weeks

• Muscle strength--6 meters gait speed

  12 weeks

Study Arms (2)

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

Dietary Supplement: Ensure Complete powder; Other: verbal nutrition education

Control group

OTHER

just give the verbal nutrition education.

Other: verbal nutrition education

Interventions

Ensure Complete powder DIETARY_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

Intervention group

verbal nutrition education OTHER

give the verbal nutrition education

Control group; Intervention group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Study Officials

• Ting Zhao

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technologist-in-charge

Model Details: the subjects will be randomized into intervention group and control group.

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: August 27, 2018
• Study Start: May 20, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

CN (1)