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
Verified date | January 2016 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Interventional |
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.
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 |
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
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 |
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