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

Undernutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656186
• Other study ID #: YO_elderly
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2016
• Last updated: January 15, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 86 Years

Eligibility

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

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• Pre-intervention
First 2-weeks : keeping routine dietary habit
• Liquid nutritional 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prealbumin (mg/dL)		at pre-treatment (week -2)	Yes
Primary	Prealbumin (mg/dL)		at baseline (week 0)	Yes
Primary	Prealbumin (mg/dL)		at post-treatment (week 2)	Yes
Primary	Transferrin (mg/dL)		at pre-treatment (week -2)	Yes
Primary	Transferrin (mg/dL)		at baseline (week 0)	Yes
Primary	Transferrin (mg/dL)		at post-treatment (week 2)	Yes
Secondary	Weight (kg)	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)	4 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Osmolality (mOsm/kgH2O)	3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)	4 weeks	Yes