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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Rand

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Indonesia University

Current Primary Outcome:

  • 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)
  • 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)
  • MNA score [ Time Frame: 2 weeks ]
    MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indonesia University

Dates:
Date Received: February 19, 2017
Date Started: October 5, 2016
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017