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

Phase 3

Completed

• Conditions: Undernutrition
• Interventions: Dietary Supplement: Pre-intervention; Dietary Supplement: Liquid nutritional supplement

• Registration Number: NCT02656186
• Lead Sponsor: Yonsei University

Brief Summary

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

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 Timeline

• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-14
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm pretest-posttest	Pre-intervention	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.
Single-arm pretest-posttest	Liquid nutritional supplement	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.

Primary Outcome Measures

Name	Time	Method
Prealbumin (mg/dL)	at post-treatment (week 2)
Transferrin (mg/dL)	at post-treatment (week 2)

Secondary Outcome Measures

Name	Time	Method
Weight (kg)	4 weeks	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Serum albumin (g/dL)	4 weeks	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Insulin growth factor-1 (ng/mL)	4 weeks	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Osmolality (mOsm/kgH2O)	4 weeks	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Body mass index (kg/m2)	4 weeks	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)