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

Deglutition Disorders Clinical Trial

— IMMUGOLD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445309
• Other study ID #: CEIPSA-2023-PR-0024
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

Other:
• Sensory test of functional plant-based drink
Once the volunteers have been recruited, a telephone interview lasting less than 10 minutes will be carried out where what the study consists of will be explained as well as the information sheet for the participant will be read to them so that they understand what the study consists of. study. Once the necessary questions have been asked according to the inclusion criteria, if the participant enters the study, data such as name, surname, age, gender, smoker, consumer of vegetable drinks, pathologies and contact information will be collected. If the participant does not enter the study, their personal data will no longer be collected and they will be informed that according to the exclusion criteria they can no longer participate in the study. Once these data are obtained, it will be randomized using the EXCEL program.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory test of a functional plant-based drink	Sensory attributes will be assessed.	immediatly after intervention
Secondary	Oral health	To test the oral health of the early elderly population. Geriatric Oral Health Assessment Index (GOHAI TEST). Consists in a little questionnaire of 12 questions items classified by Yes, always; F, frequently; AV, sometimes; RV, rarely; N, never.	immediatly after intervention
Secondary	Dysphagia	To test the dysphagia status of the early elderly population. Eating Assessment Tool EAT-10 TEST. Consists in a little questionnaire of 10 items classified punctued betwen 0-4 being 0 any problem and 4 severe problem.	immediatly after intervention