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

Yonsei University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Undernutrition

Interventions

Pre-interventionDIETARY_SUPPLEMENT

First 2-weeks : keeping routine dietary habit

Liquid nutritional supplementDIETARY_SUPPLEMENT

Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)

Eligibility

Sex: ALLMin age: 65 YearsMax age: 86 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Prealbumin (mg/dL)

Time frame: at pre-treatment (week -2)

Prealbumin (mg/dL)

Time frame: at baseline (week 0)

Prealbumin (mg/dL)

Time frame: at post-treatment (week 2)

Transferrin (mg/dL)

Time frame: at pre-treatment (week -2)

Transferrin (mg/dL)

Time frame: at baseline (week 0)

Transferrin (mg/dL)

Time frame: at post-treatment (week 2)

Secondary Outcomes

Weight (kg)

3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

Time frame: 4 weeks

Body mass index (kg/m2)

3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

Time frame: 4 weeks

Serum albumin (g/dL)

3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

Time frame: 4 weeks

Insulin growth factor-1 (ng/mL)

3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

Time frame: 4 weeks

Data from ClinicalTrials.gov

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