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Completed

NCT Number: NCT03065595

The Effect of Ophiocephalus Striatus Extract on Levels of IGF-1, Albumin, and MNA Score in Elderly With Malnutrition

This study is a double-blind randomized controlled trial comparing the effect of Ophiocephalus striatus extract in elderly patients with malnutrition. The measured outcomes are the level of IGF-1, albumin, and MNA score.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This research was conducted in Cipto Mangunkusumo General Hospital and M. Djamil General Hospital, in collaboration with Biomedical Laboratory Faculty of Medicine University of Andalas and Prodia Laboratory, Indonesia. The inclusion criteria were elderly patients (≥ 60 y.o.) with malnutrition (MNA score ≤ 23,5) and hypoalbuminaemia (< 3,5 g/dL), had been treated, and permitted to leave from the hospital. All participants had been interviewed and physically examined to measure the anthropometric profile. Investigators also measured participant's Activity of Daily Living ADL Barthel, Geriatric Depression Scale (GDS), and Abbreviated Mental Test (AMT) to assess participant's compliance for consuming Ophiocephalus striatus extract. Blood samples were obtained to measure participant's level of IGF-1 and albumin before intervention.

Recruited-randomized participants were classified into two groups (control and intervention) with double-blind scheme. Intervention group was given the extract 5 grams two times/day for two weeks. After two weeks, all participants were invited back to out-patient clinic in hospital. MNA score was measured after the intervention. Blood sample were obtained again to know if there were any changes in IGF-1 level and albumin level.

Finally, investigators analyzed results to generate the conclusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patient (≥ 60 y.o.)
  • Malnutrition or high risk for malnutrition (MNA score ≤ 23,5)
  • Hypoalbunemia (albumin level < 3,5 g/dL)

Exclusion criteria

  • chronic liver disease (liver cirrhosis) or severe liver dysfunction or increasing ALT > 3x normal
  • renal dysfunction with glomerulus filtration rate (< 30mL/minute)
  • nephrotic syndrome
  • acute infection / stroke / trauma
  • neoplasma
  • depression with Geriatric Depression Scale > 10
  • hypersensitivity to Ophiocephalus striatus
  • receive parenteral albumin
  • refuse to accept the treatment

Treatment and study plan

Ophiochepalus striatus extract

Dietary Supplement

each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day

Other names: VIP ALBUMIN

Placebo

Other

each sachet of placebo drug is poured into 50 mL normal water and drink two times/day

Primary outcomes

  1. Serum IGF-1

    Time frame: 2 weeks

    IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)

  2. Serum albumin

    Time frame: 2 weeks

    Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)

  3. MNA score

    Time frame: 2 weeks

    MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effect of Ophicephalus Striatus Extract on Levels of Insulin-like Growth Factor-1 (IGF-1), Albumin, and Mini Nutritional Assessment Score in Elderly Patients With Malnutrition: A Double Blind Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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