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Biscuit breakthrough? pea protein and vitamin d may slow muscle aging

NCT ID NCT07356440

Prevention Sponsor: University of Udine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study looks at whether eating special biscuits made with pea protein and taking vitamin D can help prevent sarcopenia—the age-related loss of muscle mass and strength. Researchers will recruit 74 adults aged 65-80 with early signs of muscle loss. For 12 weeks, half will eat the protein biscuits and take vitamin D drops, while the other half get plain biscuits and placebo drops. The goal is to see if this simple diet change can slow muscle decline and improve quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Given the multifactorial, heterogeneous nature of sarcopenia, volunteers will be enrolled if they meet at least one of the following three diagnostic criteria : * Ishii equation values: patients with a score ≥105 for males and ≥120 for females will be included. The Ishii screening test is a widely used method that estimates the probability of sarcopenia using a score derived from an equation based on three variables: age, grip strength, and calf circumference. * Appendicular skeletal muscle mass index (ASMI): \<7.0 kg/m2 for males and \<5.5 kg/m2 for females. * Short physical performance battery score ≤8 In addition, the following inclusion criteria are considered: * Body mass index ≥19 \<30 kg/m2 * Ability to act Exclusion criteria * Age \<65 or \>80 years; * Body mass index \<19 or ≥30 kg/m²; * Diagnosis of cancer within the previous five years; * Regular intake of vitamin D supplements; * Dysphagia and difficulty chewing; * Allergy or other intolerances to gluten; * Allergy to eggs; * Intestinal disorders (Crohn's disease, ulcerative colitis, bacterial overgrowth syndrome, constipation, coeliac disease, irritable bowel syndrome) that could affect the gut microbiota; * Pacemaker recipients; * Acute inflammation (CRP \>10 mg/L); * Anaemia (haemoglobin \<13 g/dL in men; \<12 g/dL in women); * Renal failure (glomerular filtration rate (GFR) \>45 mL/min/1.73 m²); * Chronic liver disease (transaminases \< 40 IU in men, \< 35 IU/L in women); * Inability to act

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Conditions

The condition(s) this trial relates to.

Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biomarkers / blood Microbiome analysis Muscle mass and strength Nutritional intervention Quality of life outcomes Sarcopenia Sarcopenia in elderly

Contacts and locations

Locations

  • Department of Agricultural, Food, Environmental and Animal Sciences

    Udine, Udine, 33100, Italy

  • Laboratory of Immunology, Department of Medicine

    Udine, Udine, 33100, Italy

  • Outpatient Clinic of Internal Medicine 2, Central Friuli University Health Authority (ASU FC)

    Udine, Udine, 33100, Italy

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