Clinical trial NCT06445309: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Deglutition Disorders
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 80-100 healthy volunteers between 60-75 years old are needed to carry out this sensory tasting study in untrained tasters, the target population of this functional drink. According to Gacula and Rutenbeck, 2005, The sample size ranges from 20 to 200 to detect a difference ranging between 0.0 and 1.0 on a 9-point hedonic scale. For the simulated consumer data, the significant difference was first observed with a difference of 0.60 when n = 40. Factors such as the age of the participants and the number of sensory attributes it is recommended to increase the number of participants, concluding that Between 40-100 participants would be enough to observe a difference above 0.6. Furthermore, according to the European Sensory Network, 2011, for sensory tasting studies with hedonic attributes, between 80-100 participants are recommended.

All participants will try the same vegetable drink.

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.


Eligibility criteria: Inclusion criteria:

- Men or women ≥60 years old \<75 years old; Written informed consent provided prior to the sensory tasting study.

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.

Primary outcomes:
measure: Sensory test of a functional plant-based drink
timeFrame: immediatly after intervention
Secondary outcomes:
measure: Oral health
timeFrame: immediatly after intervention
measure: Dysphagia
timeFrame: immediatly after intervention
Other outcomes:
Locations:
Study officials:
References: