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

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ClinicalTrials.gov Identifier: NCT02656186
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Undernutrition Dietary Supplement: Pre-intervention Dietary Supplement: Liquid nutritional supplement Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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)




Primary Outcome Measures :
  1. Prealbumin (mg/dL) [ Time Frame: at pre-treatment (week -2) ]
  2. Prealbumin (mg/dL) [ Time Frame: at baseline (week 0) ]
  3. Prealbumin (mg/dL) [ Time Frame: at post-treatment (week 2) ]
  4. Transferrin (mg/dL) [ Time Frame: at pre-treatment (week -2) ]
  5. Transferrin (mg/dL) [ Time Frame: at baseline (week 0) ]
  6. Transferrin (mg/dL) [ Time Frame: at post-treatment (week 2) ]

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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. 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)

  5. 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)



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Ages Eligible for Study:   65 Years to 86 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656186


Sponsors and Collaborators
Yonsei University
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02656186     History of Changes
Other Study ID Numbers: YO_elderly
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Nutrients
Growth Substances
Physiological Effects of Drugs