Clinical trial NCT02656186: Supplementation With Nutrients Modulating IGF-1 and Cytokines in Elderly People at Risk of Undernutrition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Undernutrition
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 86
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prealbumin (mg/dL)
timeFrame: at pre-treatment (week -2)
measure: Prealbumin (mg/dL)
timeFrame: at baseline (week 0)
measure: Prealbumin (mg/dL)
timeFrame: at post-treatment (week 2)
measure: Transferrin (mg/dL)
timeFrame: at pre-treatment (week -2)
measure: Transferrin (mg/dL)
timeFrame: at baseline (week 0)
measure: Transferrin (mg/dL)
timeFrame: at post-treatment (week 2)
Secondary outcomes:
measure: Weight (kg)
timeFrame: 4 weeks
measure: Body mass index (kg/m2)
timeFrame: 4 weeks
measure: Serum albumin (g/dL)
timeFrame: 4 weeks
measure: Insulin growth factor-1 (ng/mL)
timeFrame: 4 weeks
measure: Osmolality (mOsm/kgH2O)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Food & Nutrition, College of Human Ecology, Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
name: Jong Ho Lee, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Kim M, Kim M, Lee YJ, Song HJ, Shim JK, Chang DH, Yu WK, Lee SH, Lee JH. Supplementation with nutrients modulating insulin-like growth factor-1 negatively correlated with changes in the levels of pro-inflammatory cytokines in community-dwelling elderly people at risk of undernutrition. J Hum Nutr Diet. 2017 Feb;30(1):27-35. doi: 10.1111/jhn.12447. Epub 2016 Dec 9.