Normal-fat versus fat-restricted diets in patients with acute pancreatitis: A randomized controlled study (NouRish-AP study).

Background/objectives: International guidelines recommend a low-fat diet (LFD) in patients with acute pancreatitis (AP); however, no randomized controlled trials have compared LFD with a normal fat diet (NFD). The necessity of LFD remains uncertain, with concerns about its palatability and lower energy density potentially leading to reduced intake and quality of life (QoL). This study evaluates the efficacy and safety of NFD versus LFD in patients with mild to moderately severe non-hypertriglyceridemic AP.

Methods: This randomized controlled study enrolled patients from July 2022 to April 2023. Participants were randomly assigned to either NFD (30 % of total calories from fat) or LFD (15 % of total calories from fat). The primary outcome was daily energy intake. Secondary outcomes included QoL, complications, length of stay (LOS), and 90-day readmission.

Results: Sixty-five patients were enrolled (33 NFD, 32 LFD). The NFD group had significantly higher energy intake during the first two intervention days (Day 1: 18.7 vs. 12 kcal/kg/day, p = 0.007; Day 2: 18.6 vs. 12.7 kcal/kg/day, p = 0.005) and in the malnourished subgroup (23.2 vs. 15.6 kcal/kg/day, p = 0.024). However, overall energy intake was not significantly different (18.9 vs. 16.5 kcal/kg/day, p = 0.087). NFD resulted in significantly higher QoL scores in the physical (53.9 vs. 39.4, p = 0.019) and mental domains (55.9 vs. 40.7, p = 0.004). No significant differences were found in abdominal pain, triglyceride increment, infections, LOS, or 90-day readmission.

Conclusions: NFD was associated with higher calorie intake during the first two days of oral feeding in patients with mild and moderately severe AP, along with better QoL and no increase in adverse events. Routine LFD prescription may not be necessary, making NFD a viable option for non-hypertriglyceridemic AP patients.

Clinical Trial Registration: The trial was registered, and the protocol is available online at Thaiclinicaltrials.org (Identifier: TCTR20230926008).