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 (Immugold)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Immune System
• Intervention / Treatment: Dietary supplement: Functional plant-based beverage; Dietary supplement: Control Beverage

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Pedret Figuerola, Doctor; Phone Number: +34 977 759 375; Email: anna.pedret@urv.cat

Study Locations

• Spain
  • Tarragona
    • Reus, Tarragona, Spain, 43201
      • Universitat Rovira i Virgili
      • Contact: Anna Pedret Figuerola, Doctor; Phone Number: +34977759375; Email: anna.pedret@urv.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional plant-based beverage; 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; 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.
Placebo Comparator: Control beverage; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers	Oxidized LDL (oxLDL) (ug/mL) assessed by commercial ELISA in blood samples	Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers	Oxidized methionine (Met/SO/Met) (ng/mL) assessed by commercial ELISA in blood samples	Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers	Superoxide Dismutase (SOD) (U/g Hb) assessed by enzymatic assays in blood samples	Visit 1 ("Week 0"), visit 3 ("Week 12")
Oxidative markers	Glutathione peroxidase (GSHPx) (nmol/mL) assessed by enzymatic assays in blood samples	Visit 1 ("Week 0"), visit 3 ("Week 12")
Immunologic parameters	Lymphocytes T cells (CD4 and CDB) (cells/µL) assessed by ELIspot in blood samples	Visit 1 ("week 0", visit 3 ("week 12")
Immunologic parameters	Lymphocytes B cells (cells/µL) assessed by immunofluorescence in blood samples.	Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters	Immunoglobulins (IgM) (cells/µL) assessed by ELISA kits in serum samples.	Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters	Immunoglobulins (IgG) (cells/µL) assessed by ELISA kits in serum samples.	Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters	Immunoglobulins (IgA) (cells/µL) assessed by ELISA kits in saliva samples.	Visit 1 ("week 0"), visit 3 ("week 12")
Immunologic parameters	Immunoglobulins (IgE) (cells/µL) assessed by ELISA kits in serum samples.	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	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	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	Visit 1 ("Week 0"), visit 3 ("Week 12")
Glucose homeostasis	Homeostasis model assessment index (HOMA-i) calculated from fasting glucose and insulin.	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).	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).	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).	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).	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).	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).	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).	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).	Visit 1 ("Week 0"), visit 3 ("Week 12")
Anthropometric and muscle health measurements	Waist circumference (cm) measured by steel measuring tape (at the umbilicus).	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.	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)	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).	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).	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)	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).	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)	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	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).	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.	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.	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.	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.	Visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Dietary record	3-day dietary record assessed by a nutritional composition database.	Visit 1 ("week 0"), visit 2 ("week 6"), visit 3 ("week 12")
Frailty assessment	Fried frailty phenotype (weight loss, exhaustion, grip strenght, low physical activity, slow walking pace)	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).	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.	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).	Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota	Short chain fatty acids (µmol/g) assessed by gas chromatography in faecal samples.	Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota	Bile acids (µmol/g) assessed by gas chromatography in faecal samples.	Visit 1 ("week 0"), visit 3 ("week 12")
Gut microbiota	Sterols (µg/g) assessed by gas chromatography in faecal samples.	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.	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.	Visit 1 ("week 0"), visit 3 ("week 12")
Vital Signs	Blood pressure (mmHg) assessed by OMRON M6 Comfort (HEM-7360-E)	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)	Visit 0 ("Week -1"), 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.	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.	Visit 1 ("week 1"), 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.	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.	Visit 1 ("week 0"), visit 3 ("week 12")

Collaborators and Investigators

• Sponsor: University Rovira i Virgili

Study record dates

Study Major Dates

• Study Start (Estimated): February 9, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: nutritional status; inflammation; sarcopenia; immune system; cognitive impairment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Mental Disorders; Pathologic Processes; Pathological Conditions, Anatomical; Neurocognitive Disorders; Cognition Disorders; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cognitive Dysfunction; Inflammation; Sarcopenia
• Other Study ID Numbers: Immugold Study; CPP2023-010565 (Other Grant/Funding Number: Ministerio de Ciencia, Innovación y Universidades and the Agencia Estatal de Investigación)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No