Novel immune-modulating formula versus standard formula for gastrointestinal cancer patients at risk of malnutrition undergoing surgery: A pilot randomized controlled trial.

Preoperative immunonutrient supplementation was associated with a significant reduction in preoperative hs-CRP concentrations compared to standard formula.

• Change in hs-CRP was -4.4 mg/L in the immunonutrient group versus +4.5 mg/L in the standard formula group (p = 0.030).
• hs-CRP was measured at baseline, preoperative, and postoperative periods.
• 30 patients were enrolled total, with 15 per group.
• Patients had Nutrition Risk Score (NRS) 2002 ≥ 3, indicating nutritional risk.

Preoperative immunonutrient supplementation was associated with a greater increase in body weight compared to the standard formula.

• Body weight increased by 1.9 kg in the immunonutrient group versus 0.3 kg in the standard formula group (p = 0.041).
• Both groups received 2 servings/day providing 360 kcal and 17 g protein per serving.
• The supplementation period was 10-14 days preoperatively.
• Sample size was 15 patients per group in this pilot trial.

No significant differences were observed in postoperative clinical outcomes between the immunonutrient and standard formula groups.

• No significant differences were found in postoperative complications, hospital stay, 30-day readmission, or mortality.
• The study was a randomized, double-blind pilot trial with 30 total patients.
• Serum IL-6 and TNF-alpha were also measured but no significant between-group differences were reported for these markers.
• The authors note that further studies with larger populations are needed to validate findings.

Compliance and acceptance of the novel curcumin-containing immunonutrient formula were high with minimal gastrointestinal adverse events.

• The formula was described as having high compliance and acceptance among patients.
• Gastrointestinal adverse events were characterized as minimal.
• Each serving provided 360 kcal and 17 g protein, with 2 servings administered per day.
• The supplementation was administered for 10-14 days preoperatively.

The study enrolled gastrointestinal cancer patients at nutritional risk undergoing surgery, assessed using the Nutrition Risk Score (NRS) 2002.

• Eligibility required NRS 2002 ≥ 3, indicating nutritional risk.
• This was a randomized, double-blind pilot trial.
• 30 patients were enrolled and randomized to 15 per group.
• The trial is registered at ClinicalTrials.gov (NCT06825221).
• Inflammatory markers (hs-CRP, IL-6, TNF-alpha) and nutrition outcomes were assessed at baseline, preoperative, and postoperative time points.