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Therapeutic Effects of Butyrate on Pediatric Obesity: A Randomized Clinical Trial
Serena Coppola1,2, Rita Nocerino1,2, Lorella Paparo1,2
1Department of Translational Medical Science, University of Naples "Federico II," Naples, Italy.
Insights
Oral butyrate supplementation significantly improved BMI and reduced obesity markers in children. This study suggests butyrate as a promising adjunct therapy for pediatric obesity management.
Area of Science:
- Pediatric Endocrinology
- Nutritional Science
- Gastroenterology
Background:
- Pediatric obesity presents a significant health challenge, necessitating novel and effective treatment strategies.
- The gut microbiome's role in metabolic health is increasingly recognized, highlighting potential therapeutic targets.
Purpose of the Study:
- To evaluate the efficacy of oral sodium butyrate as an adjunct to standard care for treating pediatric obesity.
- To assess the impact of butyrate supplementation on body mass index (BMI) and various metabolic and inflammatory markers in children.
Main Methods:
- A randomized, quadruple-blind, placebo-controlled trial involving 54 children aged 5-17 years with obesity.
- Participants received standard care plus either oral sodium butyrate (20 mg/kg/day) or placebo for six months.
- Primary outcome was a decrease in BMI standard deviation (SD) scores; secondary outcomes included changes in waist circumference, glucose, insulin, lipids, ghrelin, microRNA-221, IL-6, and gut microbiome composition.
Main Results:
- Children receiving butyrate showed a significantly higher rate of BMI decrease (96% vs. 56%) compared to placebo.
- Butyrate supplementation led to significant reductions in waist circumference, insulin levels, HOMA-IR, ghrelin, microRNA-221, and IL-6.
- Adherence was similar between groups, with mild, transient side effects (nausea, headache) in a few patients.
Conclusions:
- Oral butyrate supplementation appears to be an effective adjunctive treatment for pediatric obesity.
- Butyrate may improve metabolic profiles and reduce inflammatory markers in obese children, warranting further investigation.
Importance:
The pediatric obesity disease burden imposes the necessity of new effective strategies.
Objective:
To determine whether oral butyrate supplementation as an adjunct to standard care is effective in the treatment of pediatric obesity.
Design, Setting, And Participants:
A randomized, quadruple-blind, placebo-controlled trial was performed from November 1, 2020, to December 31, 2021, at the Tertiary Center for Pediatric Nutrition, Department of Translational Medical Science, University of Naples Federico II, Naples, Italy. Participants included children aged 5 to 17 years with body mass index (BMI) greater than the 95th percentile.
Interventions:
Standard care for pediatric obesity supplemented with oral sodium butyrate, 20 mg/kg body weight per day, or placebo for 6 months was administered.
Main Outcomes And Measures:
The main outcome was the decrease of at least 0.25 BMI SD scores at 6 months. The secondary outcomes were changes in waist circumference; fasting glucose, insulin, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride, ghrelin, microRNA-221, and interleukin-6 levels; homeostatic model assessment of insulin resistance (HOMA-IR); dietary and lifestyle habits; and gut microbiome structure. Intention-to-treat analysis was conducted.
Results:
Fifty-four children with obesity (31 girls [57%], mean [SD] age, 11 [2.91] years) were randomized into the butyrate and placebo groups; 4 were lost to follow-up after receiving the intervention in the butyrate group and 2 in the placebo group. At intention-to-treat analysis (n = 54), children treated with butyrate had a higher rate of BMI decrease greater than or equal to 0.25 SD scores at 6 months (96% vs 56%, absolute benefit increase, 40%; 95% CI, 21% to 61%; P < .01). At per-protocol analysis (n = 48), the butyrate group showed the following changes as compared with the placebo group: waist circumference, -5.07 cm (95% CI, -7.68 to -2.46 cm; P < .001); insulin level, -5.41 μU/mL (95% CI, -10.49 to -0.34 μU/mL; P = .03); HOMA-IR, -1.14 (95% CI, -2.13 to -0.15; P = .02); ghrelin level, -47.89 μg/mL (95% CI, -91.80 to -3.98 μg/mL; P < .001); microRNA221 relative expression, -2.17 (95% CI, -3.35 to -0.99; P < .001); and IL-6 level, -4.81 pg/mL (95% CI, -7.74 to -1.88 pg/mL; P < .001). Similar patterns of adherence to standard care were observed in the 2 groups. Baseline gut microbiome signatures predictable of the therapeutic response were identified. Adverse effects included transient mild nausea and headache reported by 2 patients during the first month of butyrate intervention.
Conclusions And Relevance:
Oral butyrate supplementation may be effective in the treatment of pediatric obesity.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04620057.
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