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Clinical Trials/NCT06445309
NCT06445309
Not Yet Recruiting
N/A

Design and Development of a Functional Plant-based Beverage Formulated According to the Main Nutritional Guides for Early Elderly Requirements to Improve Nutritional Status and Immunity for the Early Elderly People to Get Well-healthy Ageing

University Rovira i Virgili0 sites80 target enrollmentSeptember 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deglutition Disorders
Sponsor
University Rovira i Virgili
Enrollment
80
Primary Endpoint
Sensory test of a functional plant-based drink
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

Populations around the world are aging and this demographic transition will impact almost every aspect of society. Furthermore, the COVID-19 pandemic has highlighted the seriousness of gaps in policies, systems and services. According to the World Health Organization (WHO) plan for 2021-2030, a decade of concerted global action on healthy ageing is urgently needed to ensure that older people can realize their potential in dignity and equality in nutritional requirements. An effective way to address the inherent demographic change, which translates into the health status of older people, is through the maintenance of adequate nutritional status. Public health services require new funding to address this problem, but if we bring new strategies to health policies, by improving nutrition, we could impact the reduction of costs at the level of medical care in the ageing population. In older people, according to the latest guidelines on nutritional requirements in geriatrics from the Spanish Nutrition Foundation (FEN), the British Nutrition Foundation and The European Society for Clinical Nutrition and Metabolism (ESPEN), multinutrient strategies instead of mononutrient strategies, are gaining importance due to relevant scientific evidence based on controlled and randomized clinical trials. Therefore, following the nutritional requirements in healthy ageing, an important aspect is to strengthen immunity in this population.

Consequently, the food industry is booming in the development of new functional alternatives, such as plant-based beverages, which are well positioned in the market and can offer healthy functional beverage options to people of early elderly age (60 to 75 years) as a target population due to the ease with which they are ingested. Therefore, investments in small and medium-sized companies to encourage the incorporation of trained doctoral personnel and add innovation value to this type of product are essential for resilience.

Therefore, the present proposal hypothesizes that, following the nutritional needs for healthy ageing, a multinutrient-optimized beverage as a functional food can improve immunity and reduce inflammation and oxidation in women and men in the elderly population.

Registry
clinicaltrials.gov
Start Date
September 2024
End Date
February 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Rovira i Virgili
Responsible Party
Principal Investigator
Principal Investigator

Rosa Sola

Clinical professor

University Rovira i Virgili

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Type 2 diabetes
  • Chronic alcoholism
  • Early community-dwelling seniors
  • Failure to comply with study guidelines.
  • Selection criteria
  • Volunteers will be recruited through several ways:
  • general databases of participants from previous clinical trials of the NFOC-Salut group
  • Leaflets with study information, as well as contact information, will be distributed in health centers, civic centers and social centers.
  • The information will be disseminated through brochures with contact information among the people who are registered in the IMSERSO to select those who meet the inclusion criteria according to the study population in order to reach the largest number of subjects possible.

Outcomes

Primary Outcomes

Sensory test of a functional plant-based drink

Time Frame: immediatly after intervention

Sensory attributes will be assessed.

Secondary Outcomes

  • Dysphagia(immediatly after intervention)
  • Oral health(immediatly after intervention)

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