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

NCT07409480 | Not Yet Recruiting

• 2 other identifiers: Immugold StudyCPP2023-010565
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In 2018, for the first time, the number of people aged 65 and over exceeded the number of children under the age of 5. A rise in ageing societies is coming, and new efforts are needed to ensure that this increase in life expectancy is accompanied by years of health and a good quality of life. The new focus for our ageing society will be an extended healthspan, the period of life spent in good health. This is an important shift, as population ageing is a defining global trend of our time. By 2030, 1 in 6 people in the world will be 60 years and older, according to the World Health Organization. In this sense, the imperative to maintain the health and activity levels of the senior demographic has never been more critical. Advances in healthcare, science, and technology have contributed to increased longevity, yet this does not always equate to improved health. The prevalence of malnutrition or the risk thereof among the elderly living independently in Europe ranges from 13.5% to 29.7%, highlighting a pressing need for nutritional intervention. Addressing this, the pursuit of innovative nutritional sources and the creation of new food products enriched with these sources are essential to bridging the nutritional gap, ensuring healthier aging prospects for this population. The formulation of food products tailored to the elderly must consider their unique nutritional requirements, particularly concerning protein and micronutrient intake. Recent advances in food technology facilitate the development of plant-based beverages that are palatable, nutritionally adequate, and accessible. Moreover, the growing market share of plant-based non-dairy beverages provides a promising alternative, offering opportunities to deliver bioactive compounds with health-promoting properties, appealing to health-conscious and lactose-intolerant consumers. Given the nutritional challenges and health risks faced by the aging population, particularly in relation to protein intake and malnutrition, another critical aspect that warrants attention is the immune system's health through diet. The immune system, which naturally weakens with age, plays a crucial role in the elderly's ability to resist infections and recover from illnesses. Research highlights the impact of not only macronutrients but micronutrients such as vitamins D, C, E, and zinc on enhancing immune responses, suggesting that diets rich in these nutrients can significantly benefit immune health in older adults. Strengthening the immune system through diet becomes even more pertinent considering the increased vulnerability of the elderly to infectious diseases, including respiratory infections like influenza and pneumonia, which are leading causes of morbidity and mortality in this population. Developing food products that are not only nutritionally adequate but also tailored to support immune function could provide a dual benefit: improving general health and enhancing the body's defence mechanisms. The present research project is structured into three coordinated phases and is enabled by the multidisciplinary nature of the IMMUGOLD consortium. In the first phase, AZTI conducted an extensive literature and technical review to identify functional ingredients capable of supporting immune function while remaining compatible with the technological, sensory, and stability requirements of a plant-based beverage. This process identified vitamin D, zinc, FOS, and L-leucine as the most suitable bioactive components, considering bioavailability, processing stability, and expected physiological effects. In the second phase, COSTA carried out the development and reformulation of the oat-based beverage to ensure nutritional adequacy, ingredient stability under thermal treatment, and organoleptic acceptability for older consumers. Finally, the third phase involves a clinical study, to be executed by Universitat Rovira i Virgili (URV), which aims to evaluate the effects of the newly developed fortified beverage on markers of immune function and systemic inflammation in community-dwelling older adults, with secondary outcomes including nutritional status and other health-related parameters relevant to ageing. The multidisciplinary expertise of the consortium, including computational modelling, ingredient research, nutrition, food product development, and clinical epidemiology, ensures the feasibility of the project and the successful achievement of its objectives: AZTI provides evidence-based solutions for functional ingredients; COSTA develops innovative plant-based beverages; and URV contributes extensive experience in designing and implementing nutritional programs and clinical studies.

Conditions

Inflammation; Immune System

Keywords

inflammation; immune system; nutritional status; sarcopenia; cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Change in serum hsCRP

  The primary outcome measure will be the change in serum hsCRP (mg/dL) assessed by high-sensitivity immunoturbidimetry standardized methods on a Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain). It has been suggested that values \> 0.2 mg/dL of hsCRP increased the likelihood of developing cardiovascular disease or ischemic events. Consequently, changes in hsCRP involve changes in clinical impact.

  Visit 1 ("Week 0"), visit 3 ("Week 12")

Secondary Outcomes (60)

• Inflammation markers and inflammatory cytokines

  Visit 1 ("Week 0"), visit 3 ("Week 12")

• Inflammation markers and inflammatory cytokines

  Visit 1 ("Week 0"), visit 3 ("Week 12")

• Inflammation markers and inflammatory cytokines

  Visit 1 ("Week 0"), visit 3 ("Week 12")

• Inflammation markers and inflammatory cytokines

  Visit 1 ("Week 0"), visit 3 ("Week 12")

• Inflammation markers and inflammatory cytokines

  Visit 1 ("Week 0"), visit 3 ("Week 12")

Study Arms (2)

Functional plant-based beverage

EXPERIMENTAL

250 mL/day of the multi-ingredient plant-based functional beverage consumed at any time throughout the day + balanced dietary recommendations for the elderly population.

Dietary Supplement: Functional plant-based beverage

Control beverage

PLACEBO COMPARATOR

250mL/day of the plant-based beverage without functional selected study ingredients consumed at any time throughout the day + balanced dietary recommendations for the elderly population.

Dietary Supplement: Control Beverage

Interventions

Functional plant-based beverage DIETARY_SUPPLEMENT

250 mL/day of the multi-ingredient plant-based functional beverage consumed at any time throughout the day + balanced dietary recommendations for the elderly population.

Functional plant-based beverage

Control Beverage DIETARY_SUPPLEMENT

250mL/day of the plant-based beverage without functional selected study ingredients consumed at any time throughout the day + balanced dietary recommendations for the elderly population.

Control beverage

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥60 years old \<80 years old.
• Written informed consent provided before the initial screening visit.

You may not qualify if:

• Hypoglycaemic treatment or type 1 and type 2 diabetes mellitus diagnosed.
• Anaemia (haemoglobin ≤13 g/dL in men and ≤12 g/dL in women).
• Intestinal malabsorption diseases, such as chron disease, colitis ulcerous, and irritable bowel syndrome.
• Immune pathology or depressed immune system.
• Use of antioxidants or nutritional supplements.
• Known allergy or hypersensitivity to oat, coconut, or any formulation ingredient.
• Renal diseases or history of hypercalcemia, sarcoidosis, or hyperparathyroidism.
• History of inborn errors of metabolism affecting branched-chain amino acid metabolism.
• Chronic alcoholism.
• Failure to follow the study guidelines.

Sponsors & Collaborators

• University Rovira i Virgili: lead

Study Sites (1)

Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

Location

MeSH Terms

Conditions

Inflammation; Sarcopenia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Anna Pedret Figuerola, Doctor

CONTACT

+34 977 759 375; anna.pedret@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 13, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)