← Human Trials & Peer-Reviewed Studies

Impact of an oral nutritional supplement on the recovery of the nutritional status of older patients with fragility hip fracture: Controlled and randomized clinical trial.

Plain-language guide to PMID 40398561 (2025): double-blind randomized controlled trial of Copper (Supplement).

Key Facts

PMID
40398561
Journal
Clinical nutrition ESPEN
Year
2025
Study type
Randomized Controlled Trial
Authors
Fernández Jiménez R et al. (14 authors)
DOI
10.1016/j.clnesp.2025.05.025

What This Study Did, in Plain Language

What Was Tested

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

Hip fracture due to fragility (HFF) has a high mortality rate and leads to a decline in quality of life due to advanced age and compromised nutritional status, among others.

The aim of this study was to evaluate the impact of early nutritional intervention (hyperproteic and hypercaloric oral nutritional supplement; HP/HC-ONS) on the nutritional and functional recovery of older patients with HFF.

Who Took Part

PubMed indexes the participants as older adults and people over 80, both men and women.

Double-blind, placebo-controlled clinical trial in patients >65 years old with scheduled HFF surgery (≤72 h).

Nutritional diagnosis was based on Mini Nutritional Assessment (MNA), and "morphofunctional assessment": a combination of body composition techniques, such as bioelectrical impedance analysis (BIA) with phase angle (PhA), and nutritional ultrasound (US) with rectus femoris cross-sectional area (RF-CSA) and circumference; and muscle function measured using handgrip strength (HGS).

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

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

As a double-blind Copper (Supplement) study, the assignments were hidden from both participants and investigators until the end.

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

Primary statistical analysis endpoints were changes between baseline and 4-month PhA and HGS.

Laboratory parameters (C reactive protein and prealbumin, amongst others), dependency (Barthel index), and disease burden (Charlson Comorbidity Index, CCI) were registered.

All measurements took place at baseline, 2-month (except for BIA), and 4-month on-site visits.

Hospital length of stay (LoS) was extracted from health records.

Adverse events (AEs) were reported, and product tolerability was assessed by stool frequency and the Bristol Stool Form Scale (BSFS).

What Was Measured

PubMed files the paper under topics including Hip Fractures, Dietary Supplements, Nutritional Status, Hand Strength, Body Composition, Nutrition Assessment and Geriatric Assessment.

Author keywords: Hip fracture due to fragility, Malnutrition, Morphofunctional status and Oral nutritional supplement.

What This Means in Plain Language

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

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2025 (Clinical nutrition ESPEN), a journal based in England.

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

Our Notes on the Compound

Copper (Supplement): The active site of cytochrome c oxidase is described as containing copper ions that are essential for electron transfer.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.