NCT03065595

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ophiochepalus striatus extract	each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day
OTHER	Placebo	each sachet of placebo drug is poured into 50 mL normal water and drink two times/day

Timeline

• Start date: 2016-10-05
• Primary completion: 2016-12-30
• Completion: 2017-02-14
• First posted: 2017-02-28
• Last updated: 2017-02-28