Effects of biscuit supplementation fortified with zinc, glutamine, prebiotics, and dietary fiber on intestinal mucosal rehabilitation in children aged 12-18 months with undernutrition

Primary Investigator

  • Dr. Eva Jeumpa Soelaeman, University Indonesia

Study Period

January 2017 - December 2018

Study Description

Malnutrition is still a problem in developing countries such as Indonesia. Undernutrition can cause damage to the mucus in the intestines (intestinal atrophy) causing problems in the intestines including not being able to absorbed nutrients, problems with the pancreas, and lactose intolerance. Intestinal atrophy in malnourished children can be rehabilitated with improving intestinal mucosal thickness in malnourished infants after nutritional rehabilitation. Supplementation of some nutritional components is essential in regenerating the intestinal mucosa. Some components of nutrients that can repair the intestinal mucosa include glutamine, zinc, prebiotics, and dietary fiber. In this research, biscuits will be fortified with glutamine, zinc, probiotics, and dietary fiber as therapy to improve the integrity of intestinal mucosa in children with undernutrition. The aim of this study is to see if the intestinal mucus and nutrition status can be improved with fortified biscuits in children.

Interventions are performed by giving biscuits fortified with glutamine, zinc, prebiotics, and dietary fiber to the subjects. The subjects of 68 people are randomly allocated to one of two groups, namely 34 people in the intervention group and 34 control groups. Randomisation is done by block technique 4 (four). Interventions are double-blinded with biscuit packaging, both fortified and placebo, made in the same form and packaging, differing only in content. In the intervention group, participants receive fortified biscuits as much as two pieces per day as a dietary supplement. Those in the control group receive a placebo biscuit as much as two pieces per day as a dietary supplement.

Study Arms

  • Intervention: fortified biscuits as much as two pieces per day as a dietary supplement.
  • Control: placebo biscuit as much as two pieces per day as a dietary supplement.

Primary Outcomes

  • Improvement in intestinal integrity in undernourished children 12-18 months with improvement in markers of bowel integrity through examination of Intestinal Fatty Acid Binding Protein (IFABP), Alpha-1-Antitrypsin (AAT), and Calprotectin in children ages 1
  • Improvement in nutrient absorption, marked with improvement in Steatocrite level measured using “stool” tests, ELISA method at baseline, 3 and 6 months
  • Improvement in nutritional status. Nutritional status is based on improvement in Z-Score (WHZ and HAZ), measured at the end of every month during 6 months of intervention.

Study Intervention

  • Standard Fortified Food Blends

Research Gaps

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

Study Population