Deglutition DisordersIMMUGOLDNCT06445309
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
An observational study of Deglutition Disorders, run by University Rovira i Virgili.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- Sensory test of functional plant-based drink
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Men or women ≥60 years old <75 years old; Written informed consent provided prior to the sensory tasting study.
Who cannot join
- Type 2 diabetes
- Chronic alcoholism
- Early community-dwelling seniors
- Failure to comply with study guidelines.
- Selection criteria
- Volunteers will be recruited through several ways:
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- 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.
About this study
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.
- Conditions
- Deglutition Disorders
- Being tested
- Sensory test of functional plant-based drink
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory test of functional plant-based drinkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Between 80-100 healthy volunteers between 60-75 years old are needed to carry out this sensory tasting study in untrained tasters.
Additionally, the participant will be given a form to assess the Geriatric Oral Health Assessment Index (GOHAI) and a form for the assessment of dysphagia (EAT-10) to assess the participant's sensory perceptions, as well as any oral health problems. oral health that could interfere with the results of the sensory tasting. Receives: Other: Sensory test of functional plant-based drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory test of a functional plant-based drink
Sensory attributes will be assessed.
Measured: immediatly after intervention
Secondary outcomes (2)
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.
Measured: immediatly after intervention
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.
Measured: immediatly after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445309
- Sponsor's protocol ID
- CEIPSA-2023-PR-0024
- Acronym
- IMMUGOLD
- Status last verified
- Jun 2024
- First submitted
- 15 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06445309
- Acronym / sponsor ID
- IMMUGOLD / CEIPSA-2023-PR-0024
- Conditions
- Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Sensory test of functional plant-based drinkBetween 80-100 healthy volunteers between 60-75 years old are needed to carry out this sensory tasting study in untrained tasters. Additionally, the participant will be given a form to assess the Geriatric Oral Health Assessment Index (GOHAI) and a form for the assessment of dysphagia (EAT-10) to assess the participant's sensory perceptions, as well as any oral health problems. oral health that could interfere with the results of the sensory tasting. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Men or women ≥60 years old <75 years old; Written informed consent provided prior to the sensory tasting study.
Key exclusion criteria (9 listed)
- Type 2 diabetes
- Chronic alcoholism
- Early community-dwelling seniors
- Failure to comply with study guidelines.
- Selection criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory test of functional plant-based drinkOnce 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. | Other | Group 1 |
Primary outcome
Sensory test of a functional plant-based drink
Time frame: immediatly after intervention
Sensory attributes will be assessed.
2 secondary outcomes
Oral health
Time frame: immediatly after intervention
Dysphagia
Time frame: immediatly after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders, run by University Rovira i Virgili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory test of a functional plant-based drink (time frame: immediatly after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.