Evidence map›Paper›PMID 37880167›Full record

Trial reportBMJ open2023

Effects of PROtein enriched MEDiterranean Diet and EXercise on nutritional status and cognition in adults at risk of undernutrition and cognitive decline: the PROMED-EX Randomised Controlled Trial.

Nicola Ann Ward, Rachel Reid-McCann, Lorraine Brennan, Christopher R Cardwell, Cpgm de Groot, Stefania Maggi, Noel McCaffrey, Bernadette McGuinness, Michelle C McKinley, Marianna Noale and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05166564 (A Randomised Controlled Trial to Evaluate the Effect of a Protein Enriched Mediterranean Diet and Exercise Intervention on the Nutritional Status and Cognitive Performance of Adults At Risk of Undernutrition and Cognitive Decline), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05166564 nacompletednot on this map

A Randomised Controlled Trial to Evaluate the Effect of a Protein Enriched Mediterranean Diet and Exercise Intervention on the Nutritional Status and Cognitive Performance of Adults At Risk of Undernutrition and Cognitive Decline

TypeinterventionalSponsorQueen's University, BelfastRan2022 to 2025Enrolled105ConditionsCognitive Impairment, Poor Nutrition, Cognitive DeclineArmsA Protein Enriched Mediterranean Diet (PROMED) Intervention, A Protein Enriched Mediterranean Diet & Exercise (PROMED-EX) Intervention
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 7 institutions in 6 countries.

Nicola Ann WardCentre for Public Health, Queen's University Belfast, Belfast, UK.ORCID 0000-0002-4591-8443
Rachel Reid-McCannCentre for Public Health, Queen's University Belfast, Belfast, UK.
Lorraine BrennanSchool of Agriculture and Food Science, Institute of Food and Health and Conway Institute, University College Dublin, Dublin, Ireland.
Christopher R CardwellCentre for Public Health, Queen's University Belfast, Belfast, UK.
Cpgm de GrootDivision of Human Nutrition, Wageningen University, Wageningen, The Netherlands.
Stefania MaggiNeuroscience Institute, Aging Branch, National Research Council, Padua, Italy.
Noel McCaffreyExWell Medical, Irish Wheelchair Association, Dublin, Ireland.
Bernadette McGuinnessCentre for Public Health, Queen's University Belfast, Belfast, UK.
Michelle C McKinleyCentre for Public Health, Queen's University Belfast, Belfast, UK.
Marianna NoaleNeuroscience Institute, Aging Branch, National Research Council, Padua, Italy.
Roisin F O'NeillCentre for Public Health, Queen's University Belfast, Belfast, UK.
Federica PrinelliInstitute for Biomedical Technologies, Epidemiology Unit, National Research Council, Segrate, Italy.
Giuseppe SergiDepartment of Medical Sciences, University of Ferrara, Ferrara, Italy.
Caterina TrevisanDepartment of Medical Sciences, University of Ferrara, Ferrara, Italy.
Dorothee VolkertInstitute for Biomedicine of Aging, Friedrich-Alexander-Universitat Erlangen-Nurnberg, Nuremberg, Germany.
Jayne V WoodsideCentre for Public Health, Queen's University Belfast, Belfast, UK.
Claire T McEvoyCentre for Public Health, Queen's University Belfast, Belfast, UK c.mcevoy@qub.ac.uk.
Queen's University Belfast · GBNeuroscience Institute · ITUniversity of Ferrara · ITFriedrich-Alexander-Universität Erlangen-Nürnberg · DEInstitute of Biomedical Technologies · ITUniversity College Dublin · IEWageningen University & Research · NL

Funding

Medical Research Council
6 · The paper itself

Abstract

introductionUndernutrition leading to unplanned weight loss is common in older age and has been linked to increased dementia risk in later life. Weight loss can precede dementia by a decade or more, providing a unique opportunity for early intervention to correct undernutrition and potentially prevent or delay cognitive impairment. The combined effects of diet and exercise on undernutrition have not yet been evaluated. The objective of this trial is to determine the effect of a protein-enriched Mediterranean diet, with and without exercise, on nutritional status and cognitive performance in older adults at risk of undernutrition and cognitive decline.

methodsOne hundred and five participants aged 60 years and over at risk of undernutrition and with subjective cognitive decline will be recruited to participate in a 6-month, single-blind, parallel-group randomised controlled trial. Participants will be block randomised into one of three groups: group 1-PROMED-EX (diet+exercise), group 2-PROMED (diet only) and group 3-standard care (control). The primary outcome is nutritional status measured using the Mini Nutritional Assessment. Secondary outcomes include cognitive function, nutritional intake, body composition, physical function and quality of life. Mechanistic pathways for potential diet and exercise-induced change in nutritional status and cognition will be explored by measuring inflammatory, metabolic, nutritional and metabolomic biomarkers. ETHICS AND DISSEMINATION: The study is approved by the UK Office for Research Ethics Committee (ref: 21/NW/0215). Written informed consent will be obtained from participants prior to recruitment. Research results will be disseminated to the public via meetings and media and the scientific community through conference presentations and publication in academic journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05166564).

Indexed as

Cognitive DysfunctionDementiaDiet, MediterraneanMalnutritionAgedCognitionHumansMiddle AgedNutritional StatusProteinsQuality of LifeSingle-Blind MethodWeight LossProteinsDementiaNutritionNUTRITION & DIETETICSPREVENTIVE MEDICINEPUBLIC HEALTH

Identifiers

PMID37880167
PMCPMC10603411
OpenAlexW4387948482

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.