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MalnutritionSENIORNCT05853874

Development of Sustainable Eating Pattern to Limit Malnutrition in Older Adults

A study testing Nutrition intervention (dietary protocol) in people with Malnutrition and Sarcopenia, run by University of Pavia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings, since malnutrition is highly prevalent, clinically relevant and potentially treatable conditions. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Malnutrition, Sarcopenia
What is being tested?
Nutrition intervention (dietary protocol)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2024to Jan 2026
Phase
Interventional
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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 65 years old
  • Admission to two Scientific Hospitalization and Treatment Institutions in Pavia, Italy
  • Informed consent written and signed
  • Malnutrition (GLIM diagnosis)

Who cannot join

  • Dysphagia
  • Prior nutritional medical treatment
  • Terminal disease
  • History of gastric bypass, anorexia nervosa, liver failure
  • Dementia or severe confusion (MMSE score<24/30)
  • Patients with tumor diagnosis not in remission and currently not treated with oncological therapy
  • Patients with chronic or acute respiratory failure
  • Barthel index score < 70/100

About this study

Official title: Sustainable Eating Pattern to Limit Malnutrition in Older Adults

The SENIOR STUDY is aimed at improving the condition of older adults and malnutrition management in and out Italian hospital settings, since malnutrition is highly prevalent, clinically relevant and potentially treatable conditions. This study consist of two phases: an initial cross-sectional phase and a secondary nutritional intervention phase (RCT).

The SENIOR RCT aim to evaluate the efficacy of a 6 months nutrition protocol intervention compared to hospital standard care on malnourished older adults. Physical and nutritional status will be evaluated through anthropometric measures, blood exams and physical performance. In addition, the individual health perception will be evaluated.

It is expected to find an improvements of the physical and nutritional status.

Read the detailed description

The SENIOR RCT is a multicenter study conducted in two North Italian Scientific Hospitalization and Treatment Institution in Pavia on older malnourished adults (≥ 65 years old). The estimated duration is 24 months, which include 6 months of nutritional intervention and a follow-up after 6 months, with an preferred starting date on January 2024.

The primary objective of the SENIOR RCT is the evaluation of the efficacy of a 6 months sustainable nutrition protocol on malnourished older adults participants (diagnosed with the most recent GLIM criteria) in comparison to the hospital standard of care.

Therefore, the primary endpoint is the improvement of the nutritional status between pre- and post-intervention between experimental and control group measuring the change of body weight and strength (handgrip).

Secondary objectives are the change pre- and post-intervention between experimental and control group for blood biomarkers, dietary habits, quality of life and evaluation of sarcopenia.

Secondary endpoints are the change pre- and post-intervention between experimental and control group for blood biomarkers, MEDI-LITE score, SF-12, diet composition, phase angle and gait speed.

Participants of this study are older adults over 65 previously enrolled in the SENIOR cross-sectional study and willing to participate to the RCT phase or new enrolled patients from the two hospitals in according to the eligible criteria. Malnutrition will be diagnosed according to GLIM criteria, using Malnutrition Universal Screening Tool (MUST) as screening tool.

The experimental group at the baseline will receive a nutritional assessment followed by the elaboration of a sustainable and personalized nutritional protocol by qualified dietitians. The intervention will last 6 months with a monthly evaluation of the dietary consumption of the previous 24 hour (recall-24h), followed by a final follow-up after additional 6 months.

For both groups at the baseline will be measured blood biomarkers, anthropometric variables, Mediterranean diet adherence, quality of life, strength (handgrip) and locomotion (gait speed). At 3 months weight and strength will be evaluated. At 6- and 12-months baseline measurements will be repeated except for the nutritional assessment.

Dietary habits will be evaluated through a Mediterranean diet questionnaire (MEDI-LITE), while quality of life will be measured with Short-Form Health Survey (SF-12) questionnaire. Anthropometric variables include weight, height (knee height and demi-span), waist circumference, and body composition (BIA). In addition, strength (handgrip) and locomotion (gait speed) will be evaluated. Strength (handgrip), Appendicular Skeletal Mass (ASM) and locomotion (gait speed) are necessary to diagnose sarcopenia according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) consensus. Malnutrition will be evaluated again at 6 months.

Blood analysis will be carried out on a subgroup to evaluate the participants' inflammatory, nutritional and clinical status.

Being tested
Nutrition intervention (dietary protocol), Hospital standard of care
Keywords
Nutrition intervention, older adults, malnutrition, sustainability, 24-h recall, sarcopenia, nutritional protocol
Medical subject headings
Malnutrition, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition intervention (dietary protocol)Other

    The nutrition intervention sought to improve participants' overall diet quality, taking into account a sufficient intake of carbohydrates, lipids, fibres and micronutrients (vitamins and minerals), promoting proper fruits and vegetables consumption and variety. About water intake, considering the high dehydration risk in older persons highlighted by the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines, its adequate consumption is recommended and encouraged.

  • Hospital standard of careOther

    The standard clinical procedures following the malnutrition diagnoses will be implemented according to the routine of the two hospitals

Study groups in NCT05853874
Study groupRoleWhat they receive
Nutritional interventionExperimentalNutritional intervention consist in a macro- and micronutrients balanced nutritional protocol with a focus on sustainability and personalized according to the individual malnutrition severity. In particular, an adequate coverage of energy, protein and water requirements will be guaranteed according to Italian reference values (LARN) and European (ESPEN) guidelines. In light of the scientific literature and the principal issues founding in malnourished older people, the proposed nutritional protocol will provide an adequate and sustainable consumption of animal and vegetable proteins and an appropriate water intake. The nutritional intervention will be carried out by a qualified staff.
Receives: Other: Nutrition intervention (dietary protocol)
ControlOtherThe control group receive the standard of care provided for malnutrition treatment by hospitals
Receives: Other: Hospital standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in nutritional status pre- and post- intervention between experimental and control group measuring weight

    Weight gain= + 2kg

    Measured: 24 months (baseline, 3 months, 6 months and 12 months)

  2. Change in nutritional status pre- and post- intervention between experimental and control group measuring strength

    Increase in strength = + 1 kg

    Measured: 24 months (baseline, 3 months, 6 months and 12 months)

Secondary outcomes (24)

  1. Changes pre- and post- intervention between experimental and control groups for complete blood count

    Red blood cells (10^9/L), white blood cells (10^12/L or %), hemoglobin (g/dl), hematocrit (%), platelets (10^9/L).

    Measured: 24 months (baseline and 6 months)

  2. Changes pre- and post- intervention between experimental and control groups for blood lipid profile

    low density lipoprotein (mmol/l), high density lipoprotein (mg/dl), total colesterol (mg/dl), triglicerydes (mg/dl)

    Measured: 24 months (baseline and 6 months)

  3. Changes pre- and post- intervention between experimental and control groups for blood C reactive Protein (CRP)

    C reactive Protein (CRP) (mg/dl)

    Measured: 24 months (baseline and 6 months)

  4. Changes pre- and post- intervention between experimental and control groups for blood transaminases

    (glutamic oxaloacetic transaminase, Glutamic-Pyruvic Transaminase, gamma-glutamyl transferase) (U/I) Alkaline phosphatase (U/L)

    Measured: 24 months (baseline and 6 months)

  5. Changes pre- and post- intervention between experimental and control groups for blood creatin Kinase

    Creatin Kinase (UI/L)

    Measured: 24 months (baseline and 6 months)

  6. Changes pre- and post- intervention between experimental and control groups for blood prealbumin

    prealbumin (g/mL)

    Measured: 24 months (baseline and 6 months)

  7. Changes pre- and post- intervention between experimental and control groups for blood cytokine

    interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α, transforming tumor factor-β (pg/ml)

    Measured: 24 months (baseline and 6 months)

  8. Changes pre- and post- intervention between experimental and control groups for glycemia.

    glycemia (mg/dl)

    Measured: 24 months (baseline and 6 months)

  9. Changes pre- and post- intervention between experimental and control groups for blood insulin

    Insulin (µU/mL)

    Measured: 24 months (baseline and 6 months)

  10. Changes pre- and post- intervention between experimental and control groups for blood homocysteine

    Homocysteine (µmol/L)

    Measured: 24 months (baseline and 6 months)

  11. Changes pre- and post- intervention between experimental and control groups for blood vitamine D

    vitamine D (ng/ml)

    Measured: 24 months (baseline and 6 months)

  12. Changes pre- and post- intervention between experimental and control groups for blood vitamine B12

    vitamine 12 (pg/ml)

    Measured: 24 months (baseline and 6 months)

  13. Changes pre- and post- intervention between experimental and control groups for blood vitamine B9

    vitamine 9 (ng/mL)

    Measured: 24 months (baseline and 6 months)

  14. Changes pre- and post- intervention between experimental and control groups for blood sodium (Na)

    Na (mmol/L)

    Measured: 24 months (baseline and 6 months)

  15. Changes pre- and post- intervention between experimental and control groups for blood potassium (K)

    K (mEq/l)

    Measured: 24 months (baseline and 6 months)

  16. Changes pre- and post- intervention between experimental and control groups for blood magnesium (Mg)

    Mg (mEq/l)

    Measured: 24 months (baseline and 6 months)

  17. Changes pre- and post- intervention between experimental and control groups for blood calcium (Ca)

    Ca (mg/dL)

    Measured: 24 months (baseline and 6 months)

  18. Changes pre- and post- intervention between experimental and control groups for blood iron (Fe)

    Fe (μg)

    Measured: 24 months (baseline and 6 months)

  19. Changes pre- and post- intervention between experimental and control groups for blood zinc (Zn)

    Zn (mmol/l)

    Measured: 24 months (baseline and 6 months)

  20. Changes pre- and post- intervention between experimental and control groups for adherence to Mediterranean Diet

    Medi-Lite adherence score.score ranges between 0-18. A high score represents a higher adherence to Mediterranean diet.

    Measured: 24 months (baseline, 6 months and 12 months)

  21. Changes pre- and post- intervention between experimental and control groups for the quality of life

    Short-Form Health Survey 12. Total score ranges between 0-100. A higher score represents a better quality of life

    Measured: 24 months (baseline, 6 months and 12 months)

  22. Changes pre- and post- intervention between experimental and control groups for the dietary nutritional composition

    Improvements of dietary composition evaluated with monthly 24-h recalls

    Measured: 24 months (baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months)

  23. Changes pre- and post- intervention between experimental and control groups of fat free mass

    Improvement of the phase angle (θ) measured by bioimpedance analysis

    Measured: 24 months (baseline, 6 months and 12 months)

  24. Changes pre- and post- intervention between experimental and control groups in locomotion test

    Velocity walking increase measured with gait speed test

    Measured: 24 months (baseline, 6 months and 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Why it stopped: The RCT phase was not started due to delays in obtaining the approval by the reference Ethics Committees, logistical difficulties in starting recruitment, and low number of eligible participants.

Resources

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
Model description
Randomized Control Trial with two parallel arms. The intervention group will receive a nutritional protocol and the control group will receive the standard of care
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853874
Sponsor's protocol ID
22042023
Other IDs
CUP: F13C22001210007
Acronym
SENIOR
Status last verified
Apr 2026
First submitted
26 Apr 2023
Last updated
5 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition intervention (dietary protocol) in people with Malnutrition and Sarcopenia, run by University of Pavia.

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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 5 May 2026. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change in nutritional status pre- and post- intervention between experimental and control group measuring weight (time frame: 24 months (baseline, 3 months, 6 months and 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853874.

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 5 May 2026.

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