Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly (SARC-PEA)

March 18, 2026 updated by: University of Udine

Effect of Consumption of Vegetable Protein-enriched Biscuits and Vitamin D Supplementation on the Progression of Sarcopenia in Elderly Subjects

The ageing population makes it necessary to find effective strategies for the prevention of sarcopenia (the progressive loss of muscle mass and strength and a decline in physical performance) that can be counteracted with foods containing protein and adequate intake of vitamin D. This study will evaluate the effectiveness of consuming a food based on plant proteins and vitamin D supplementation. Intervention studies in humans conducted to date have mostly focused on the effect of animal proteins (mainly from whey) on disease progression. A study on the effect of pea proteins has not yet been conducted and will provide information on the effectiveness of these proteins in modulating markers linked to the disease. The effect on the gut microbiota will also be considered, as the existence of a gut-muscle axis has been suggested, in which microbial genera producing short-chain fatty acids have been linked to a positive effect on muscle mass through anabolic stimulation. Thus, the analysis of the modulation of the intestinal microbiota, through the dietary intervention proposed in this study, may represent a further step in research related to the prevention of this disease. Sarcopenic volunteers aged between 65 and 80 will be recruited to consume either a shortbread biscuit made with wheat flour enriched with hydrolysed pea protein and a vitamin D supplement in extra virgin olive oil, or a control biscuit and a placebo (extra virgin olive oil) for 12 weeks. The study will be randomised, parallel, single-blind. The effect of consuming the experimental biscuit and vitamin D supplementation compared to that of a traditional control biscuit and a placebo oil solution will be evaluated on certain markers related to sarcopenia. In particular, the following will be considered: muscle strength, measuring grip strength and leg strength (chair stand test); muscle mass through the measurement of appendicular muscle mass, and the calculation of the appendicular muscle mass index; physical performance using the Short Physical Performance Battery; the inflammatory response and other blood biomarkers related to sarcopenia. In addition, the following will be assessed: dietary habits through a food diary and quality of life through the SarQoL questionnaire. Finally, the effect of nutritional intervention on the modulation of the gut microbiota will be evaluated through 16S rRNA sequencing and bioinformatic analysis of the data.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Sarcopenia, characterized by the age-related loss of muscle mass, strength, and physical performance, is a growing public health concern given the global aging population. Physical activity-the standard treatment-is often not feasible for frail or bedridden elderly individuals, highlighting the need for alternative strategies. Nutritional interventions, particularly those involving protein and vitamin D supplementation, have shown promise in managing sarcopenia.

This randomized, single-blind, parallel-design clinical trial aims to evaluate the effect of consuming a shortbread biscuit enriched with hydrolyzed pea protein, combined with a daily dose of vitamin D3 (20 μg/day, 800 IU/day), on muscle mass, muscle strength, physical performance, and gut microbiota composition in sarcopenic individuals aged 65-80 years. The study will enroll 74 participants meeting specific inclusion criteria.

Participants will be randomly assigned to one of two groups:

  1. Intervention Group: Receives a 50 g daily portion of a functional biscuit enriched with hydrolyzed pea protein, and 2 drops/day of a vitamin D3 supplement (providing 20 μg/day).
  2. Control Group: Receives a similar biscuit without added protein and a placebo oil (extra virgin olive oil) in replace of vitamin D3.

The intervention will last for 12 weeks. Measurements will be taken at baseline, mid-point (6 weeks), and study end (12 weeks), including handgrip strength, chair stand test, bioimpedance-based muscle mass, and SPPB. Blood samples will be analyzed for markers related to inflammation (e.g., CRP, IL-6, TNF-α), oxidative stress (oxLDL), anabolic signaling (IGF-1), and vitamin D status (25-hydroxycholecalciferol), among others. Gut microbiota composition and short-chain fatty acid (SCFA) production will be assessed via stool sample analysis and 16S rRNA sequencing.

Participants will also complete quality-of-life (SarQoL) and food frequency questionnaires, along with 3-day dietary diaries at each time point. Compliance will be monitored via dietary diary entries and return of supplement containers. A sample size of 74 participants (32 per group + 15% dropout) was calculated to detect a 25% difference in treatment success (as defined by surpassing the sarcopenia threshold in ASMI).

The study further investigates the potential of plant-based protein sources, particularly hydrolyzed pea protein, to serve as effective dietary interventions in the elderly. It also explores the gut-muscle axis, examining how nutritional modulation of the microbiota may impact sarcopenia-related outcomes.

The trial is conducted at the Internal Medicine Unit 2 of the S. Maria della Misericordia Hospital (Udine, Italy) under the coordination of Prof. Alessandro Cavarape. All procedures follow ethical guidelines and include appropriate monitoring for adverse events.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Udine
      • Udine, Udine, Italy, 33100
        • Department of Agricultural, Food, Environmental and Animal Sciences
      • Udine, Udine, Italy, 33100
        • Laboratory of Immunology, Department of Medicine
      • Udine, Udine, Italy, 33100
        • Outpatient Clinic of Internal Medicine 2, Central Friuli University Health Authority (ASU FC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein-enriched biscuit + Vitamin D3
Participants will consume daily one portion (50 g) of experimental biscuits made with wheat flour and pea protein hydrolysate, and take 2 drops of vitamin D3 supplement in extra virgin olive oil.
Other: Protein-enriched biscuits
Daily portion (50 g) of biscuits made with wheat flour and pea protein hydrolysate. Used in the Experimental Arm.
Dietary supplement: Vitamin D3 supplement
Two daily drops of vitamin D3 dissolved in extra virgin olive oil. Used in the Experimental Arm.
Placebo Comparator: Control Biscuit + Placebo Oil
Participants will consume daily one portion (50 g) of control biscuits (same recipe without pea protein hydrolysate), and take 2 drops of placebo oil (extra virgin olive oil without vitamin D3).
Other: Control biscuit
Daily portion (50 g) of control biscuits made with wheat flour, without pea protein hydrolysate.
Other: Placebo oil
Two daily drops of placebo oil (extra virgin olive oil without vitamin D3).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Appendicular Skeletal Muscle Index (ASMI)
Time Frame: Screening, baseline, week 6 and week 12 (end of the treatment)

ASMI calculated as appendicular skeletal muscle mass in kilograms divided by height in meters squared (kg/m²). ASM and height will be measured separately and combined using this formula: "kg/m²".

ASMI values <7 kg/m2 for men, and <5.5 kg/m2 for women indicate the condition of sarcopenia as indicated by the European Working Group on Sarcopenia in Older People.
Screening, baseline, week 6 and week 12 (end of the treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strenght
Time Frame: Screening, baseline, week 6 and week 12 (end of the treatment)

The muscle strenght will be measured using two different analysis Handgrip Strength: Measured using Electronic Hand Dynamometer EH101, dominant hand, two attempts. The cut-off point for the diagnosis of sarcopenia are <27 kg for men, and <16 kg for women as indicated by the European Working Group on Sarcopenia in Older People.

Chair Stand Test: Number of stands in 30 seconds without upper limb support. The cut of for the diagnosis of sarcopenia is >15 s for five rises as indicated by the European Working Group on Sarcopenia in Older People.
Screening, baseline, week 6 and week 12 (end of the treatment)
Physical performance (SPPB score)
Time Frame: Screening, baseline, week 6 and week 12 (end of the treatment)
Short Physical Performance Battery (balance tests, 4-meter walk, 5 sit-to-stand repetitions). The scale for SPPB is between 0 and 12. The cut-off points for the diagnosis of sarcopenia is ≤8 point score as indicated by the European Working Group on Sarcopenia in Older People.
Screening, baseline, week 6 and week 12 (end of the treatment)
C-Reactive protein (CRP)
Time Frame: Baseline, week 6 and week 12 (end of the treatment)
CRP will be measured in serum using a multiplex ELISA assay and expressed in milligrams per liter (mg/L).
Baseline, week 6 and week 12 (end of the treatment)
Gut micorbiome modulation and metabolites
Time Frame: Baseline at at week 12 (end of the treatment)
Quantification of SCFA production (via gas chromatography) and microbiota composition (16S sequencing, α-diversity, relative abundance of sarcopenia-associated genera: Roseburia, Eubacterium, Lachnospira, Ruminococcus).
Baseline at at week 12 (end of the treatment)
Nutritional intake
Time Frame: Baseline, week 6 and week 12 (end of the treatment)
3-day dietary record. This record will tracks all food and beverages consumed over 2 weekdays and 1 weekend day to analyze typical eating habits.
Baseline, week 6 and week 12 (end of the treatment)
Nutritional habits
Time Frame: Enrollment
food frequency questionnaire (FFQ). This instrument allow monitoring the past dietary habits (previous year).
Enrollment
Quality of life of sarcopenic patients
Time Frame: Baseline, week 6 and week 12 (end of the treatment)
SarQoL questionnaire to assess health-related quality of life in sarcopenic subjects. The SarQoL scale is between 0 and 100. A cut-off ≤ 60 points is indicative of sarcopenia. However, these cutoffs are not diagnostic on their own but they have been proposed as screening indicators to flag individuals who may warrant further clinical evaluation for sarcopenia using established criteria.
Baseline, week 6 and week 12 (end of the treatment)
Mini Nutritional Assessment (MNA®)
Time Frame: At the screening
The MNA® is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. The scale of MNA® is between 0 and 30. The cut-off points are 24-30 normal nutritional status; 17-23.5 risk of malnutrition; <17 malnutrition.
At the screening
Mini Mental State Examination (MMSE)
Time Frame: At the screening
It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The scale for MMSE goes from 0 to 30. Cut-off points are 24-30: No cognitive impairment; 18-23: Mild to moderate cognitive impairment; < 18: Moderate to severe cognitive impairment.
At the screening
Body mass index (BMI)
Time Frame: screening, baseline, week 6, week 12 (end of the treatment)
BMI will be calculated by dividing the body weigth in kg and the height in meters (m).
screening, baseline, week 6, week 12 (end of the treatment)
Interleukin-6 (IL-6)
Time Frame: baseline, week 6, week 12 (end of the treatment)
IL-6 will be measured in serum using a multiplex ELISA assay and expressed in picograms per milliliter (pg/mL).
baseline, week 6, week 12 (end of the treatment)
Tumor Necrosis Factor-alpha (TNF-α)
Time Frame: baseline, week 6, week 12 (end of the treatment)
TNF-α will be measured in serum using a multiplex ELISA assay (Ella, ProteinSimple) and expressed in picograms per milliliter (pg/mL).
baseline, week 6, week 12 (end of the treatment)
Leptin
Time Frame: baseline, week 6, week 12 (end of the treatment)
Leptin concentration in serum will be measured using multiplex assay kit (ELISA) and expressed as picograms per milliliter (pg/mL)
baseline, week 6, week 12 (end of the treatment)
IGF-1
Time Frame: Baseline, week 6, week 12 (end of the treatment)
Quantitative measurement of serum insulin-like growth factor-1 (IGF-1) concentration using the Thermo Fisher Human IGF-1 ELISA Kit and expressed as ng/mL.
Baseline, week 6, week 12 (end of the treatment)
Albumin
Time Frame: baseline, week 6, week 12 (end of the treatment)
Quantitative measurement of serum albumin concentration using the Thermo Fisher Human albumin ELISA Kit and expressed as ng/mL.
baseline, week 6, week 12 (end of the treatment)
Oxidized LDL (oxLDL)
Time Frame: baseline, week 6 and week 12 (end of the treatment)
Quantitative measurement of fasting serum oxidized LDL (oxLDL) concentration using the Thermo Fisher Human Oxidized LDL ELISA Kit and expressed as pg/mL.
baseline, week 6 and week 12 (end of the treatment)
25OH-D (Total 25-OH Vitamin D)
Time Frame: baseline, week 6, week 12 (end of the treatment)
Serum 25OH-D (Total 25-OH Vitamin D) will be measured using the FineTest® 25OH-D (Total 25-OH Vitamin D) ELISA Kit and expressed as ng/mL.
baseline, week 6, week 12 (end of the treatment)
Human Agrin (C-terminal fragment)
Time Frame: baseline, week 6, week 12 (end of the treatment)
Serum Human Agrin (C-terminal fragment) will be quantified using the Human Agrin (C-terminal fragment) ELISA Kit and expressed as pg/mL.
baseline, week 6, week 12 (end of the treatment)
Triglyceride (TG)
Time Frame: baseline, week 6, week 12 (end of the treatment)
Serum Triglyceride (TG) levels will be measured using Triglyceride (TG) Colorimetric Assay Kit and expressed as mmol/L.
baseline, week 6, week 12 (end of the treatment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appendicular skeletal muscle mass (ASM)
Time Frame: Screening, baseline, week 6, week 12 (end of the treatment)
Appendicular skeletal muscle mass will be measured by bioelectrical impedance analysis (BIA 101; BIVA® PRO, Akern Srl, Pisa, Italia) and expressed in kg.
Screening, baseline, week 6, week 12 (end of the treatment)
Height
Time Frame: screening, baseline
Height will be measured using a stadiometer and expressed in meters (m).
screening, baseline
Body weight
Time Frame: screening, baseline, week 6, week 12 (end of the treatment)
Body weight will be measured using a calibrated scale and expressed in kilograms (kg)
screening, baseline, week 6, week 12 (end of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Udine

Investigators

  • Principal Investigator: Alessandro Cavarape, M.D., Azienda Sanitaria Universitaria del Friuli Centrale (ASU FC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEUR-2024-Sper-39

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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