NCT02656186

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

January 12, 2016

Last Update Submit

January 15, 2016

Conditions

Undernutrition

Outcome Measures

Primary Outcomes (6)

  • Prealbumin (mg/dL)

    at pre-treatment (week -2)

  • Prealbumin (mg/dL)

    at baseline (week 0)

  • Prealbumin (mg/dL)

    at post-treatment (week 2)

  • Transferrin (mg/dL)

    at pre-treatment (week -2)

  • Transferrin (mg/dL)

    at baseline (week 0)

  • Transferrin (mg/dL)

    at post-treatment (week 2)

Secondary Outcomes (5)

  • Weight (kg)

    4 weeks

  • Body mass index (kg/m2)

    4 weeks

  • Serum albumin (g/dL)

    4 weeks

  • Insulin growth factor-1 (ng/mL)

    4 weeks

  • Osmolality (mOsm/kgH2O)

    4 weeks

Study Arms (1)

Single-arm pretest-posttest

EXPERIMENTAL

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.

Dietary Supplement: Pre-interventionDietary Supplement: Liquid nutritional supplement

Interventions

Pre-interventionDIETARY_SUPPLEMENT

First 2-weeks : keeping routine dietary habit

Single-arm pretest-posttest
Liquid nutritional supplementDIETARY_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)

Single-arm pretest-posttest

Eligibility Criteria

Age65 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27933679DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Jong Ho Lee, Ph.D.

    Department of Food & Nutrition, College of Human Ecology, Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01