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

Primary Purpose

Undernutrition

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pre-intervention
Liquid nutritional supplement
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Undernutrition

Eligibility Criteria

65 Years - 86 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single-arm pretest-posttest

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Prealbumin (mg/dL)
    Prealbumin (mg/dL)
    Prealbumin (mg/dL)
    Transferrin (mg/dL)
    Transferrin (mg/dL)
    Transferrin (mg/dL)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 12, 2016
    Last Updated
    January 15, 2016
    Sponsor
    Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02656186
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Undernutrition

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-arm pretest-posttest
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Pre-intervention
    Intervention Description
    First 2-weeks : keeping routine dietary habit
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Liquid nutritional supplement
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Prealbumin (mg/dL)
    Time Frame
    at pre-treatment (week -2)
    Title
    Prealbumin (mg/dL)
    Time Frame
    at baseline (week 0)
    Title
    Prealbumin (mg/dL)
    Time Frame
    at post-treatment (week 2)
    Title
    Transferrin (mg/dL)
    Time Frame
    at pre-treatment (week -2)
    Title
    Transferrin (mg/dL)
    Time Frame
    at baseline (week 0)
    Title
    Transferrin (mg/dL)
    Time Frame
    at post-treatment (week 2)
    Secondary Outcome Measure Information:
    Title
    Weight (kg)
    Description
    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
    Time Frame
    4 weeks
    Title
    Body mass index (kg/m2)
    Description
    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
    Time Frame
    4 weeks
    Title
    Serum albumin (g/dL)
    Description
    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
    Time Frame
    4 weeks
    Title
    Insulin growth factor-1 (ng/mL)
    Description
    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
    Time Frame
    4 weeks
    Title
    Osmolality (mOsm/kgH2O)
    Description
    3 times during 4 weeks : at pre-treatment (week -2) / at baseline (week 0) / at post-treatment (week 2)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    86 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jong Ho Lee, Ph.D.
    Organizational Affiliation
    Department of Food & Nutrition, College of Human Ecology, Yonsei University 50 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27933679
    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.
    Results Reference
    derived

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

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