InflammationImmugoldNCT07409480
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
A study testing Functional plant-based beverage in people with Inflammation and Immune System, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Immune System
- What is being tested?
- Functional plant-based beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women ≥60 years old <80 years old.
- Written informed consent provided before the initial screening visit.
Who cannot join
- 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.
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- Renal diseases or history of hypercalcemia, sarcoidosis, or hyperparathyroidism.
- History of inborn errors of metabolism affecting branched-chain amino acid metabolism.
- Chronic alcoholism.
- Current or past participation in a clinical trial or consumption of a research product in the 30 days before inclusion in the study.
- Failure to follow the study guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universitat Rovira i Virgili
Reus, Tarragona, 43201
Anna Pedret Figuerola, Doctor, +34977759375, anna.pedret@urv.cat
About this study
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.
Read more
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.
Read the detailed description
Randomised, placebo-controlled, parallel, and double-blind intervention study.
There will be 4 visits in total, attended in the Centre MQ Reus:
- Screening visit (V0, week -1):
- Information to the volunteer and signature of the informed consent.
- Revision of the eligibility criteria.
- Elaboration of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Capillary blood sampling (Finger-prick blood sampling).
- Anthropometry: waist circumference; hip; body weight and composition; height.
- Delivery of the 3-day dietary record and the material for urine, saliva, and faeces recollection for V1.
- Schedule the first visit and instructions (fasting).
- Basal visit (V1, week 0):
- Isokinetic assessment (±5 days V1) *
- Revision of the study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry: waist circumference; hip; body weight and composition; height.
- Checking the physical activity (IPAQ-E).
- Checking the quality of life (SF-36 Health survey questionnaire)
- Checking the Fraility
- Checking the Sleep quality
- Checking the Depressive symptoms
- Checking the Cognitive function (MMSE and Fototest)
- Checking the Reported illness (adapted version of the FLU-PRO plus)
- Ultrasound (muscle mass and abdominal fat).
- Checking the Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), low physical performance or physical function based on 4 m gait speed, m/s.
- Checking the 3-day dietary record
- Checking the Food Frequency Questionnaire (FFQ) adapted to the principal bioactive compounds (vitamin D, L-leucin, Zinc and FOS).
- Checking the satiety scale (VAS)
- Checking the Gastrointestinal health by Bristol Scale and Non-validated 5-item questionnaire
- Blood sample extraction.
- Collection of feaces samples.
- Collection of urine samples.
- Collection of salivary samples.
- Balanced dietary guidelines for the elderly population explanation.
- Schedule the next visit and instructions.
- Administration of plant-based beverage (intervention or control product).
- Assessment of product acceptance and purchase intention (After the first few home intakes (Week 1) by telephone) *In a subsample of n= 15 subjects, 5 days before or after the visit V10. **Isokinetics analysis in order to measure changes in muscle function through variables such as torque, work and power.
- Mid-study follow-up visit V2 (weeks 6):
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Checking the physical activity (IPAQ-E).
- Checking the Reported illness (adapted version of the FLU-PRO plus)
- Checking the FFQ
- Product intake control
- Record adverse effects
- Delivery of the 3-day dietary record and the material for urine, saliva and faeces recollection for V3.
- Schedule the next visit and instructions.
- Administration of plant-based beverage (intervention or control product). - Final visit (V3 at week 12):
- Isokinetic assessment (±5 days V1)*
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry: waist circumference; hip; body weight and composition; height.
- Checking the physical activity (IPAQ-E).
- Checking the quality of life (SF-36 Health survey questionnaire)
- Checking the Fraility
- Checking the Sleep quality
- Checking the Depressive symptoms
- Checking the Cognitive function (MMSE and Fototest)
- Checking the Reported illness (adapted version of the FLU-PRO plus)
- Ultrasound (muscle mass and abdominal fat).
- Checking the Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), low physical performance or physical function based on 4 m gait speed, m/s.
- Checking the 3-day dietary record
- Checking the Food Frequency Questionnaire (FFQ) adapted to the principal bioactive compounds (vitamin D, L-leucin, Zinc and FOS).
- Checking the satiety scale (VAS)
- Checking the Gastrointestinal health by Bristol Scale and Non-validated 5-item questionnaire
- Blood sample extraction.
- Collection of feaces samples.
- Collection of urine samples.
- Collection of salivary samples.
- Product intake control
- Record adverse effects
- Assessment of product acceptance and purchase intention *In a subsample of n= 15 subjects, 5 days before or after the visit V10.
- Isokinetics analysis in order to measure changes in muscle function through variables such as torque, work and power.
In visits V0, V1 and V3 volunteers must present themselves in fasting conditions of 8 hours to obtain fasting blood samples.
- Assessment of product acceptance and purchase intention Acceptance will be assessed at baseline and at the final visit and purchase intention will be assessed at the final visit. The questionnaire is short, requires only a few minutes to complete, and will be administered verbally in person (V3), or by phone (after V1, during the first week).
The questionnaire includes an evaluation of several attributes of the product. Participants are asked to rate each aspect on a scale from 1 to 5, where 1 indicates that the attribute is "very unpleasant" and 5 indicates that it is "very pleasant," with the option to use intermediate values to better reflect their opinion. The attributes assessed are colour, smell, appearance, flavour, texture, sweetness (in this case, 1 meaning "not sweet" and 5 meaning "very sweet"), and overall acceptance of the product.
Additionally, participants are asked to rate their intention to purchase the product on a scale from 1 to 5, where 1 corresponds to "very unlikely" and 5 to "very likely." Finally, an open section is provided for any additional comments or observations the participant may wish to share.
- Conditions
- Inflammation, Immune System
- Being tested
- Functional plant-based beverage, Control Beverage
- Keywords
- inflammation, immune system, nutritional status, sarcopenia, cognitive impairment
- Medical subject headings
- Inflammation, Sarcopenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional plant-based beverageDietary 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.
Control BeverageDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Control Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Secondary outcomes (60)
Inflammation markers and inflammatory cytokines
Interleukin-1 beta (IL-1β) (pg/mL) assessed by commercial multi-analyte ELISArray kits (R\&D Systems) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Interleukin-6 (IL-6) (pg/mL) assessed by commercial multi-analyte ELISArray kits (R\&D Systems) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Interleukin-10 (IL-10) (pg/mL) assessed by commercial multi-analyte ELISArray kits (R\&D Systems) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Uric acid (mg/dL) assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Homocysteine (µmol/L) assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Intercellular Adhesion Molecule-1 (ICAM-1) (ng/mL) assessed by commercial multi-analyte ELISArray kits (R\&D Systems) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Vascular Cell Adhesion Molecule 1 (VCAM-1) (ng/mL) assessed by commercial multi-analyte ELISArray kits (R\&D Systems) in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Tumor necrosis factor receptor 1 (TNFR-1) (ng/mL) assessed by commercial ELISA in blood samples.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Oxidized LDL (oxLDL) (ug/mL) assessed by commercial ELISA in blood samples
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Oxidized methionine (Met/SO/Met) (ng/mL) assessed by commercial ELISA in blood samples
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Superoxide Dismutase (SOD) (U/g Hb) assessed by enzymatic assays in blood samples
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Glutathione peroxidase (GSHPx) (nmol/mL) assessed by enzymatic assays in blood samples
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Immunologic parameters
Lymphocytes T cells (CD4 and CDB) (cells/µL) assessed by ELIspot in blood samples
Measured: Visit 1 ("week 0", visit 3 ("week 12")
Immunologic parameters
Lymphocytes B cells (cells/µL) assessed by immunofluorescence in blood samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Immunoglobulins (IgM) (cells/µL) assessed by ELISA kits in serum samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Immunoglobulins (IgG) (cells/µL) assessed by ELISA kits in serum samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Immunoglobulins (IgA) (cells/µL) assessed by ELISA kits in saliva samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Immunoglobulins (IgE) (cells/µL) assessed by ELISA kits in serum samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Glucose homeostasis
Fasting blood glucose (FBG) (mmol/L) assessed by standardized methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Glucose homeostasis
Insulin (IU/mL) assessed by standardized methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples
Measured: Visit 1 ("week 0", visit 3 ("week 12")
Glucose homeostasis
HGBA1c (%) assessed by standardized methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland) in blood samples
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Glucose homeostasis
Homeostasis model assessment index (HOMA-i) calculated from fasting glucose and insulin.
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Lipid profile
Total analyser (TC) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
High-density lipoprotein analyser (HDL-c) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Low-density lipoprotein analyser (LDL-c) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Triglycerides (TG) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Non-esterified fatty acids (NEFA) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Apolipoprotein A1 (ApoA1) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Apolipoprotein B100 (ApoB100) (mmol/L) in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Apo B100/ Apo A1 ratio in blood samples assessed by standardized enzymatic automated methods in an autoanalyzer (Beckman Coulter-Synchron, Galway, Ireland).
Measured: Visit 1 ("Week 0"), visit 3 ("Week 12")
Anthropometric and muscle health measurements
Waist circumference (cm) measured by steel measuring tape (at the umbilicus).
Measured: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Hip circumference (cm) measured by steel measuring tape.
Measured: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Heigh (cm) measured by wall-mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain)
Measured: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Body mass index (BMI) (kg/m²), calculated as weight (kg) divided by height squared (m²).
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Body weight and composition assessed by calibrated scale (TANITA MC-780MA; Tanita Corp., Tokyo, Japan).
Measured: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Abdominal fat distribution measured by ultrasound (VINNO 5 (Vinno (Suzhou) Co., Ltd., China)
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Muscle mass quantity and quality assessed by quadriceps ultrasound (VINNO 5 (Vinno (Suzhou) Co., Ltd., China).
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Grip strength (kg) handheld dynamometer and the maximum value from either hand will be analysed (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL)
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Physical performance (m/s) assessed by the length of the walking course divided by the time
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Isokinetic test (°s-1): the evaluation was conducted with an isokinetic dynamometer using a gold standard method (Biodex System 4; Biodex Medical Systems, NewYork, USA) by five repetitions sat two angular velocities (180°s-1, and 240°s-1). This allows a quantitative evaluation of muscle function through variables such as torque, work and power (in a subsample).
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Circulating micronutrients levels
Serum concentrations of 25-hydroxivitamin D [25(OH)D] will be quantified as the primary biomarker of vitamin D status using a validated laboratory assay.
Measured: Visit 1 ("week 1"), visit 3 ("week 12")
Circulating micronutrients levels
β-Hydroxy-β-methylbutyrate (HMB): Serum HMB concentrations will be measured as a functional biomarker of L-leucine intake and metabolism using a validated laboratory assay.
Measured: Visit 1 ("week 1"), visit 3 ("week 12")
Reported illness
To monitor global illness-like symptoms (respiratory, gastrointestinal, systemic) throughout the intervention period, we will use a shortened and adapted version of FLU-PRO Plus.
Measured: Visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Physical activity
International physical activity questionnaire for elderly: IPAQ for elderly. IPAQ-E Spanish version. Higher scores mean a better outcome.
Measured: Visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Dietary record
Food Frequency Questionnaire adaptet to the principal bioactive compounds assessed by standardized tests.
Measured: Visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Dietary record
3-day dietary record assessed by a nutritional composition database.
Measured: Visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Life Quality
SF-36 Health survey questionnaire. Higher scores mean a better outcome.
Measured: Visit 1 ("week 1"), visit 3 ("week 12")
Frailty assessment
Fried frailty phenotype (weight loss, exhaustion, grip strenght, low physical activity, slow walking pace)
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Sleep Quality
Assessed by Pittsburgh Sleep Quality Index. The maximum score is 21 points. More than 5 points are considered bad outcomes and sleep problems, and less than 5 points are considered better outcomes and no sleep problems.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Depressive symptoms
Assessed by Geriatric Depression Scale Questionnaire. The maximum puntuation is 15. The score is 0-4 no depression, 5-8 mild depression, 9-11 moderate depression and 12-15 severe depression.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Cognitive Function
Spanish validated Mini Mental State Examination test (MMSE). The MMSE test various cognitive. The total test score ranges from 0 (impaired) to 30 (normal).
Measured: Visit 1 ("Week 0"), visit 3 ("week 12")
Cognitive Function
Fototest. The Fototest is a brief and practical tool useful for identifying cognitive impairment and dementia in routine clinical practice.
Measured: Visit 1 ("Week 0"), visit 3 ("week 12")
Gut microbiota
Phyla composition functionality: Whole genomic content sequencing. Illumina platform will be used to obtain the metagenomics and metatranscriptomics of each sample following previous protocols developed in FISABIO-Salud Pública (Valencia).
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota
Short chain fatty acids (µmol/g) assessed by gas chromatography in faecal samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota
Bile acids (µmol/g) assessed by gas chromatography in faecal samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota
Sterols (µg/g) assessed by gas chromatography in faecal samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota
Faecal metabolites: buthyrate (µmol/g) assessed by gas chromatography analysis coupled to a flame ionization detector.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota
Branched chain amino acids (BCAA) (µmol/L) assessed by nuclear magnetic resonance in a Vantera clinical spectometer (LipoScience; Raleigh, NC, USA) in faecal samples.
Measured: Visit 1 ("week 0"), visit 3 ("week 12")
Vital Signs
Blood pressure (mmHg) assessed by OMRON M6 Comfort (HEM-7360-E)
Measured: Visit 0 ("Week -1"), visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Vital Signs
Resting heart rate (bpm) assessed by OMRON M6 Comfort (HEM-7360-E)
Measured: Visit 0 ("Week -1"), visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start9 Feb 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Pedret, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409480
- Sponsor's protocol ID
- Immugold Study
- Other IDs
- CPP2023-010565
- Acronym
- Immugold
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 18 Feb 2026
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07409480
- Acronym / sponsor ID
- Immugold / Immugold Study
- Conditions
- Inflammation, Immune System
- Keywords
- inflammation, immune system, nutritional status, sarcopenia, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 9 Feb 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Feb 2026 (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.
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.
Detailed description
Randomised, placebo-controlled, parallel, and double-blind intervention study.
There will be 4 visits in total, attended in the Centre MQ Reus:
- Screening visit (V0, week -1):
- Information to the volunteer and signature of the informed consent.
- Revision of the eligibility criteria.
- Elaboration of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Capillary blood sampling (Finger-prick blood sampling).
- Anthropometry: waist circumference; hip; body weight and composition; height.
- Delivery of the 3-day dietary record and the material for urine, saliva, and faeces recollection for V1.
- Schedule the first visit and instructions (fasting).
- Basal visit (V1, week 0):
- Isokinetic assessment (±5 days V1) *
- Revision of the study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry: waist circumference; hip; body weight and composition; height.
- Checking the physical activity (IPAQ-E).
- Checking the quality of life (SF-36 Health survey questionnaire)
- Checking the Fraility
- Checking the Sleep quality
- Checking the Depressive symptoms
- Checking the Cognitive function (MMSE and Fototest)
- Checking the Reported illness (adapted version of the FLU-PRO plus)
- Ultrasound (muscle mass and abdominal fat).
- Checking the Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), low physical performance or physical function based on 4 m gait speed, m/s.
- Checking the 3-day dietary record
- Checking the Food Frequency Questionnaire (FFQ) adapted to the principal bioactive compounds (vitamin D, L-leucin, Zinc and FOS).
- Checking the satiety scale (VAS)
- Checking the Gastrointestinal health by Bristol Scale and Non-validated 5-item questionnaire
- Blood sample extraction.
- Collection of feaces samples.
- Collection of urine samples.
- Collection of salivary samples.
- Balanced dietary guidelines for the elderly population explanation.
- Schedule the next visit and instructions.
- Administration of plant-based beverage (intervention or control product).
- Assessment of product acceptance and purchase intention (After the first few home intakes (Week 1) by telephone) *In a subsample of n= 15 subjects, 5 days before or after the visit V10. **Isokinetics analysis in order to measure changes in muscle function through variables such as torque, work and power.
- Mid-study follow-up visit V2 (weeks 6):
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Checking the physical activity (IPAQ-E).
- Checking the Reported illness (adapted version of the FLU-PRO plus)
- Checking the FFQ
- Product intake control
- Record adverse effects
- Delivery of the 3-day dietary record and the material for urine, saliva and faeces recollection for V3.
- Schedule the next visit and instructions.
- Administration of plant-based beverage (intervention or control product). - Final visit (V3 at week 12):
- Isokinetic assessment (±5 days V1)*
- Revision of study clinical history.
- Vital signs (blood pressure/resting heart rate).
- Checking the concomitant medication.
- Anthropometry: waist circumference; hip; body weight and composition; height.
- Checking the physical activity (IPAQ-E).
- Checking the quality of life (SF-36 Health survey questionnaire)
- Checking the Fraility
- Checking the Sleep quality
- Checking the Depressive symptoms
- Checking the Cognitive function (MMSE and Fototest)
- Checking the Reported illness (adapted version of the FLU-PRO plus)
- Ultrasound (muscle mass and abdominal fat).
- Checking the Sarcopenic parameters (muscle strength based on grip dynamometry; skeletal muscle mass index (SMI) based on bioimpedance analysis (BIA), kg/m2 and appendicular skeletal muscle mass index (ASMI) based on bioimpedance analysis (BIA), low physical performance or physical function based on 4 m gait speed, m/s.
- Checking the 3-day dietary record
- Checking the Food Frequency Questionnaire (FFQ) adapted to the principal bioactive compounds (vitamin D, L-leucin, Zinc and FOS).
- Checking the satiety scale (VAS)
- Checking the Gastrointestinal health by Bristol Scale and Non-validated 5-item questionnaire
- Blood sample extraction.
- Collection of feaces samples.
- Collection of urine samples.
- Collection of salivary samples.
- Product intake control
- Record adverse effects
- Assessment of product acceptance and purchase intention *In a subsample of n= 15 subjects, 5 days before or after the visit V10.
- Isokinetics analysis in order to measure changes in muscle function through variables such as torque, work and power.
In visits V0, V1 and V3 volunteers must present themselves in fasting conditions of 8 hours to obtain fasting blood samples.
- Assessment of product acceptance and purchase intention Acceptance will be assessed at baseline and at the final visit and purchase intention will be assessed at the final visit. The questionnaire is short, requires only a few minutes to complete, and will be administered verbally in person (V3), or by phone (after V1, during the first week).
The questionnaire includes an evaluation of several attributes of the product. Participants are asked to rate each aspect on a scale from 1 to 5, where 1 indicates that the attribute is "very unpleasant" and 5 indicates that it is "very pleasant," with the option to use intermediate values to better reflect their opinion. The attributes assessed are colour, smell, appearance, flavour, texture, sweetness (in this case, 1 meaning "not sweet" and 5 meaning "very sweet"), and overall acceptance of the product.
Additionally, participants are asked to rate their intention to purchase the product on a scale from 1 to 5, where 1 corresponds to "very unlikely" and 5 to "very likely." Finally, an open section is provided for any additional comments or observations the participant may wish to share.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional plant-based beverage | Experimental | Dietary Supplement: Functional plant-based beverage250 mL/day of the multi-ingredient plant-based functional beverage consumed at any time throughout the day + balanced dietary recommendations for the elderly population. |
| Control beverage | Placebo comparator | Dietary Supplement: Control Beverage250mL/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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women ≥60 years old <80 years old.
- Written informed consent provided before the initial screening visit.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Functional plant-based beverage250 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 Beverage250mL/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 |
Primary outcome
Change in serum hsCRP
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
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.
60 secondary outcomes
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Inflammation markers and inflammatory cytokines
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Immunologic parameters
Time frame: Visit 1 ("week 0", visit 3 ("week 12")
Immunologic parameters
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Glucose homeostasis
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Glucose homeostasis
Time frame: Visit 1 ("week 0", visit 3 ("week 12")
Glucose homeostasis
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Glucose homeostasis
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: visit 1 ("week 0"), visit 3 ("week 12")
Lipid profile
Time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")
Anthropometric and muscle health measurements
Time frame: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 0 ("week -1"), visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Anthropometric and muscle health measurements
Time frame: Visit 1 ("week 0"), visit 3 ("week 12")
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional plant-based beverage in people with Inflammation and Immune System, run by University Rovira i Virgili at 1 site in Spain.
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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Pedret Figuerola, Doctor (+34 977 759 375, anna.pedret@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum hsCRP (time frame: Visit 1 ("Week 0"), visit 3 ("Week 12")). 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 18 Feb 2026.