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

January 15, 2016 updated by: Yonsei University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 86 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-arm pretest-posttest
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-intervention
First 2-weeks : keeping routine dietary habit
Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prealbumin (mg/dL)
Time Frame: at pre-treatment (week -2)
at pre-treatment (week -2)
Prealbumin (mg/dL)
Time Frame: at baseline (week 0)
at baseline (week 0)
Prealbumin (mg/dL)
Time Frame: at post-treatment (week 2)
at post-treatment (week 2)
Transferrin (mg/dL)
Time Frame: at pre-treatment (week -2)
at pre-treatment (week -2)
Transferrin (mg/dL)
Time Frame: at baseline (week 0)
at baseline (week 0)
Transferrin (mg/dL)
Time Frame: at post-treatment (week 2)
at post-treatment (week 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight (kg)
Time Frame: 4 weeks
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
4 weeks
Body mass index (kg/m2)
Time Frame: 4 weeks
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
4 weeks
Serum albumin (g/dL)
Time Frame: 4 weeks
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
4 weeks
Insulin growth factor-1 (ng/mL)
Time Frame: 4 weeks
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
4 weeks
Osmolality (mOsm/kgH2O)
Time Frame: 4 weeks
3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Study Director: Jong Ho Lee, Ph.D., Department of Food & Nutrition, College of Human Ecology, Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YO_elderly

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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