Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 200
Population
200 children with different degrees of acute malnutrition
Methods
Double-blinded randomized controlled trial comparing RUTF with or without rice bran
Blinding
Double-blind
Duration
8 weeks
Funding
Unclear
  • Large Human Trial
  • Rigorous Journal
Background: Ready-to-use therapeutic foods (RUTFs) have been developed to treat severe acute malnutrition (SAM) in children by promoting rapid weight gain, but the long-term effects have been overlooked. Incorporating prebiotic rice bran into RUTF can enhance balanced weight gain. We hypothesized that children receiving RUTF + rice bran would exhibit increased fat-free mass (FFM) and reduced body fat percentage and abdominal adiposity. Methods: A double-blinded randomized controlled trial (ClinicalTrials.gov:NCT05319717) involving 200 children with different degrees of acute malnutrition compared the effectiveness of RUTF with or without rice bran. Children received treatment for 8 weeks, with another 8 weeks of follow-up. Anthropometry, including skinfolds, was collected every 4 weeks. Results: Compliance was similar in both groups (~21%). Children aged 6 to 23 months receiving RUTF + rice bran gained more FFM than those receiving RUTF alone (p = 0.05 at week 8). Over the 8-week treatment, the fat mass index increased in children receiving RUTF (p = 0.02), but not in those receiving RUTF + rice bran (p = 0.48), although the increase in body fat percentage was similar (p = 0.23). The ratio of abdominal to peripheral skinfolds decreased in both groups during treatment but increased during follow-up, though the difference was not statistically significant. In children aged 24 to 59 months, no significant differences in body composition were observed. The fat-free mass index increased in both groups during treatment but declined afterwards, with significant changes noted in the RUTF + rice bran group. Conclusions: The addition of rice bran to RUTF affected body composition changes during treatment only in younger children, where more lean mass was gained and fat mass gain was limited. Differences in intestinal microbiome maturity might underlie this age difference.

Research Insights

  • Children aged 6 to 23 months receiving RUTF + rice bran gained more FFM than those receiving RUTF alone (p = 0.05 at week 8).

    Effect
    Beneficial
    Effect size
    Small
  • In children aged 24 to 59 months, no significant differences in body composition were observed. The fat-free mass index increased in both groups during treatment but declined afterwards, with significant changes noted in the RUTF + rice bran group.

    Effect
    Neutral
    Effect size
    Small
  • The ratio of abdominal to peripheral skinfolds decreased in both groups during treatment but increased during follow-up, though the difference was not statistically significant.

    Effect
    Neutral
    Effect size
    Small
  • the increase in body fat percentage was similar (p = 0.23)

    Effect
    Neutral
    Effect size
    Small
  • Over the 8-week treatment, the fat mass index increased in children receiving RUTF (p = 0.02), but not in those receiving RUTF + rice bran (p = 0.48)

    Effect
    Neutral
    Effect size
    Small
  • The ratio of abdominal to peripheral skinfolds decreased in both groups during treatment but increased during follow-up, though the difference was not statistically significant.

    Effect
    Neutral
    Effect size
    Small
Back to top