Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition

Yonsei University

Status and phase: Completed; Phase 3

Conditions: Undernutrition

Treatments: Dietary Supplement: Liquid nutritional supplement; Dietary Supplement: Pre-intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02656186

YO_elderly

Details and patient eligibility

About

The purpose of this study was to determine the improvement in nutritional status, especially in the level of insulin-like growth factor-1 (IGF-1) and its relationship with changes in the circulating cytokine levels, after providing extra protein and energy contents to community-dwelling older adults at risk of undernutrition.

Full description

Sixty of aged over 65 years, living independently in the community for elderly people, nondiabetic subjects with serum prealbumin of under 30 mg/dL and BMI under 25 kg/m2 were recruited. The subjects were followed for a 2-week pre-intervention period, followed by an intervention period, which they received 2 cartons of liquid oral nutritional supplementation daily for 2 weeks.

Enrollment: 60 patients

Sex: All

Ages: 65 to 86 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• voluntarily agree to participate and sign in informed consent form
• aged 65 years or older
• a serum prealbumin level≤30 mg/dL and a BMI<25 kg/m2

Exclusion criteria

• inability to perform oral ingestion
• known allergies to milk or eggs
• an inability to communicate, such as those with Alzheimer's disease
• malabsorption syndrome, a history of gastrectomy or enterectomy
• diabetes, liver disease, renal disease, neurological disease, pancreatitis, malignancy, cardiovascular or cerebrovascular disease, metabolic syndrome
• any other disease requiring treatment, medication or alcohol abuse
• any condition that the investigator believes may put the subjects at under risk

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Single-arm pretest-posttest

Experimental group

Description:

In this study, the subjects served as their own controls. Subjects who were eligible based on inclusion criteria first entered into a 2-week pre-intervention period, during which they received nutrition counseling to keep their routine dietary habits. This was followed by an intervention period, during which an oral nutritional supplement was used over a period of 2 weeks.

Treatment:

Dietary Supplement: Liquid nutritional supplement

Dietary Supplement: Pre-intervention