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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Supplementation With Nutrients Modulating IGF-1 Negatively Correlated With Changes in the Levels of Proinflammatory Cytokines in Community-dwelling Elderly People at Risk of Undernutrition

Conditions
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Undernutrition

Intervention / Treatment
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* Dietary Supplement: Pre-intervention
* Dietary Supplement: Liquid nutritional supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm pretest-posttest<br>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. | Dietary Supplement: Pre-intervention<br>* First 2-weeks : keeping routine dietary habit<br>Dietary Supplement: Liquid nutritional supplement<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prealbumin (mg/dL) |  | at pre-treatment (week -2) | 
| Prealbumin (mg/dL) |  | at baseline (week 0) | 
| Prealbumin (mg/dL) |  | at post-treatment (week 2) | 
| Transferrin (mg/dL) |  | at pre-treatment (week -2) | 
| Transferrin (mg/dL) |  | at baseline (week 0) | 
| Transferrin (mg/dL) |  | at post-treatment (week 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) | 3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2) | 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) | 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) | 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) | 4 weeks | 
| Osmolality (mOsm/kgH2O) | 3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2) | 4 weeks |