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

NCT ID: NCT03648580

Last Updated: 2019-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ensure Complete powder

Intervention Type: 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

verbal nutrition education

Intervention Type: OTHER

give the verbal nutrition education

Control group

just give the verbal nutrition education.

Group Type: OTHER

verbal nutrition education

Intervention Type: OTHER

give the verbal nutrition education

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

verbal nutrition education

give the verbal nutrition education

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ting Zhao

Technologist-in-charge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Zhao

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

JYX201603

Identifier Type: -

Identifier Source: org_study_id