Intestinal Absorption of Lipids Using a Pancreatic Enzyme-Free Nutritional Supplement in Patients with Cystic Fibrosis: A Randomized, Double-Blind, Crossover Pilot Trial.

What Was Tested

The paper reports a study of Copper (Supplement), published as a randomized controlled trial.

The researchers evaluated serum triglyceride levels in patients with cystic fibrosis following consumption of an enzyme-modified oil oral nutritional supplement (EMO-ONS) versus a standard triacylglycerol-based ONS product (TAG-ONS) used concomitantly with PERT and patient tolerability between the two approaches.

Five subjects randomized to Arm 1 were administered a PERT placebo and EMO-ONS and 5 subjects in Arm 2 were administered TAG-ONS+PERT.

Who Took Part

The study group was 5 subjects.

Ten subjects with CF and EPI taking PERT were enrolled in a single-center, double-blind, cross-over proof of concept trial.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, crossover and pilot study.

Random assignment meant chance, not the researchers, decided who got Copper (Supplement) and who got the comparison, which limits bias.

Blinding on both sides kept the subjects and researchers unaware of who received Copper (Supplement).

The comparison arm used a placebo, so changes seen with Copper (Supplement) could be set against what happens without it.

Each person switched between Copper (Supplement) and the comparison at some point, usually with a gap in between.

Serum triglyceride levels were measured at baseline and hourly for 6 h.

What Was Measured

The researchers evaluated serum triglyceride levels in patients with cystic fibrosis following consumption of an enzyme-modified oil oral nutritional supplement (EMO-ONS) versus a standard triacylglycerol-based ONS product (TAG-ONS) used concomitantly with PERT and patient tolerability between the two approaches.

Topics PubMed links to this paper include Cystic Fibrosis, Exocrine Pancreatic Insufficiency, Intestinal Absorption, Pilot Projects and Triglycerides.

The authors tagged it with the keywords PERT-free, enzyme modified oil, nutritional supplement and pancreatic enzyme.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Copper (Supplement) in 5 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2022 (Nutrients), a journal based in Switzerland.

More context: the Copper (Supplement) compound page, all human trials.