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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02656186
Enrollment
60
Registered
2016-01-14
Start date
2015-05-31
Completion date
2015-12-31
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undernutrition

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.

Interventions

DIETARY_SUPPLEMENTPre-intervention

First 2-weeks : keeping routine dietary habit

DIETARY_SUPPLEMENTLiquid 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)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 86 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prealbumin (mg/dL)at pre-treatment (week -2)
Transferrin (mg/dL)at pre-treatment (week -2)

Secondary

MeasureTime frameDescription
Serum albumin (g/dL)4 weeks3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Weight (kg)4 weeks3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Osmolality (mOsm/kgH2O)4 weeks3 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 weeks3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
Body mass index (kg/m2)4 weeks3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026