Study to Design a Precision Nutrition Strategy At a Group Level in the Elderly

NCT05566938 | Completed

• 1 other identifier: NUTRIMET
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

From a public health point of view, personalized nutritional recommendations, at the individual level, are difficult to achieve in the short-medium term, especially in population segments with less purchasing power. Therefore, a more realistic vision in the short term and with a more favourable cost/effectiveness ratio consists of carrying out dietary advice at the group level through the identification of metabotypes, which can be defined as groups of individuals with similar metabolic profiles. The application of tailored precision nutrition aimed at the elderly is detected as a strategy to understand the different alterations associated to aging and to design innovative nutritional interventions that address this physiological process, favouring a healthy ageing.

Conditions

Aging

Keywords

metabotypes; clusters; tailored nutrition; mhealth

Outcome Measures

Primary Outcomes (1)

• Concordance between the nutritional recommendations generated at the group level and at the individual level

  To assess the concordance between the two methods used (group vs individual nutritional recommendations) the following will be considered: * How many of the nutrients identified as main objectives match between the 2 methods (in percentage) * How many nutritional recommendations generated by the 2 methods agree with each other (in percentage)

  At the final point (month 14)

Study Arms (1)

Tailored nutritional recommendations for each metabotype

OTHER

Volunteers that will be clustered into metabotypes and will recieve tailored nutritional recommendations according to their metabotype.

Other: Tailored nutritional recommendations for each metabotype

Interventions

Tailored nutritional recommendations for each metabotype OTHER

Tailored nutritional recommendations for each metabotype detected (at the group level), that will be delivered through a mobile application. Moreover, each volunteer will recieve individualized nutritional recommendations.

Tailored nutritional recommendations for each metabotype

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Men and women over 65 years of age
• Have or have access (caregiver, family member) to a smartphone or tablet with Android operating system version 6 (API 23) or higher, with internet access
• Have the signed informed consent before the initial screening visit

You may not qualify if:

• Have food allergies or intolerances
• Have diarrhea
• People with irritable bowel syndrome or inflammatory bowel disease.
• Present some severe chronic pathology with clinical manifestations such as cardiovascular disease, coronary disease, chronic kidney disease or cancer.
• Following a prescribed diet for any reason, including weight loss, in the past month.
• Recent use of antibiotics in the last two weeks.
• Consumption of prebiotics and/or probiotics in the 30 days prior to the study
• Have a BMI \<18.5 kg/m2
• Smoke more than 10 cigarettes a day
• Consume more than 14 standard drinking units (SDUs) of alcoholic beverages per week

Sponsors & Collaborators

• Fundació Eurecat: lead
• Consorci Sanitari del Maresme (CsdM): collaborator
• Centro de investigación biomédica en red enfermedades hepáticas y digestivas (Ciberhd): collaborator
• Bana Hosting: collaborator
• Sixtemia: collaborator

Study Sites (1)

Consorci Sanitari del Maresme

Mataró, Spain

Location

Study Officials

• Pere Clavé, MD, PhD

  Consorci Sanitari del Maresme (CsdM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 5, 2022
• Study Start: September 5, 2022
• Primary Completion: September 3, 2023
• Study Completion: September 3, 2023
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

ES (1)