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Randomized Controlled Trial
. 2023 Oct 25;13(10):e070689.
doi: 10.1136/bmjopen-2022-070689.

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  1 , Rachel Reid-McCann  1 , Lorraine Brennan  2 , Christopher R Cardwell  1 , Cpgm de Groot  3 , Stefania Maggi  4 , Noel McCaffrey  5 , Bernadette McGuinness  1 , Michelle C McKinley  1 , Marianna Noale  4 , Roisin F O'Neill  1 , Federica Prinelli  6 , Giuseppe Sergi  7 , Caterina Trevisan  7 , Dorothee Volkert  8 , Jayne V Woodside  1 , Claire T McEvoy  9   10
Affiliations
Randomized Controlled Trial

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 et al. BMJ Open. .

Abstract

Introduction: Undernutrition 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.

Methods: One 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).

Keywords: Dementia; NUTRITION & DIETETICS; Nutrition; PREVENTIVE MEDICINE; PUBLIC HEALTH.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Overview of PROMED-EX Study design. PROMED-EX, PROtein enriched MEDiterranean Diet and EXercise.
See this image and copyright information in PMC

References

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