Sarcopenia in ElderlySARC-PEANCT07356440
Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly
A study testing Vitamin D3 supplement and Protein-enriched biscuits in people with Sarcopenia in Elderly and Sarcopenia, run by University of Udine at 3 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Sarcopenia in Elderly, Sarcopenia, Nutritional Intervention
- What is being tested?
- Vitamin D3 supplement and Protein-enriched biscuits
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Dec 2025to Dec 2026
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Agricultural, Food, Environmental and Animal Sciences
Udine, Udine, 33100
Laboratory of Immunology, Department of Medicine
Udine, Udine, 33100
Outpatient Clinic of Internal Medicine 2, Central Friuli University Health Authority (ASU FC)
Udine, Udine, 33100
About this study
Official title: 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.
Read the 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:
- 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).
- 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.
- Conditions
- Sarcopenia in Elderly, Sarcopenia, Nutritional Intervention, Microbiome Analysis, Muscle Mass and Strength, Biomarkers / Blood
- Being tested
- Vitamin D3 supplement, Protein-enriched biscuits, Control biscuit, Placebo oil
- Keywords
- sarcopenia, elderly, pea proteins, vitamin D, snack
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 supplementDietary supplement
Two daily drops of vitamin D3 dissolved in extra virgin olive oil. Used in the Experimental Arm.
Protein-enriched biscuitsOther
Daily portion (50 g) of biscuits made with wheat flour and pea protein hydrolysate. Used in the Experimental Arm.
Control biscuitOther
Daily portion (50 g) of control biscuits made with wheat flour, without pea protein hydrolysate.
Placebo oilOther
Two daily drops of placebo oil (extra virgin olive oil without vitamin D3).
| Study group | Role | What they receive |
|---|---|---|
| Protein-enriched biscuit + Vitamin D3 | Experimental | 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. Receives: Dietary Supplement: Vitamin D3 supplement; Other: Protein-enriched biscuits |
| Control Biscuit + Placebo Oil | Placebo comparator | 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). Receives: Other: Control biscuit; Other: Placebo oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Appendicular Skeletal Muscle Index (ASMI)
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.
Measured: Screening, baseline, week 6 and week 12 (end of the treatment)
Secondary outcomes (19)
Muscle strenght
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.
Measured: Screening, baseline, week 6 and week 12 (end of the treatment)
Physical performance (SPPB score)
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.
Measured: Screening, baseline, week 6 and week 12 (end of the treatment)
C-Reactive protein (CRP)
CRP will be measured in serum using a multiplex ELISA assay and expressed in milligrams per liter (mg/L).
Measured: Baseline, week 6 and week 12 (end of the treatment)
Gut micorbiome modulation and metabolites
Quantification of SCFA production (via gas chromatography) and microbiota composition (16S sequencing, α-diversity, relative abundance of sarcopenia-associated genera: Roseburia, Eubacterium, Lachnospira, Ruminococcus).
Measured: Baseline at at week 12 (end of the treatment)
Nutritional intake
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.
Measured: Baseline, week 6 and week 12 (end of the treatment)
Nutritional habits
food frequency questionnaire (FFQ). This instrument allow monitoring the past dietary habits (previous year).
Measured: Enrollment
Quality of life of sarcopenic patients
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.
Measured: Baseline, week 6 and week 12 (end of the treatment)
Mini Nutritional Assessment (MNA®)
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.
Measured: At the screening
Mini Mental State Examination (MMSE)
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.
Measured: At the screening
Body mass index (BMI)
BMI will be calculated by dividing the body weigth in kg and the height in meters (m).
Measured: screening, baseline, week 6, week 12 (end of the treatment)
Interleukin-6 (IL-6)
IL-6 will be measured in serum using a multiplex ELISA assay and expressed in picograms per milliliter (pg/mL).
Measured: baseline, week 6, week 12 (end of the treatment)
Tumor Necrosis Factor-alpha (TNF-α)
TNF-α will be measured in serum using a multiplex ELISA assay (Ella, ProteinSimple) and expressed in picograms per milliliter (pg/mL).
Measured: baseline, week 6, week 12 (end of the treatment)
Leptin
Leptin concentration in serum will be measured using multiplex assay kit (ELISA) and expressed as picograms per milliliter (pg/mL)
Measured: baseline, week 6, week 12 (end of the treatment)
IGF-1
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.
Measured: Baseline, week 6, week 12 (end of the treatment)
Albumin
Quantitative measurement of serum albumin concentration using the Thermo Fisher Human albumin ELISA Kit and expressed as ng/mL.
Measured: baseline, week 6, week 12 (end of the treatment)
Oxidized LDL (oxLDL)
Quantitative measurement of fasting serum oxidized LDL (oxLDL) concentration using the Thermo Fisher Human Oxidized LDL ELISA Kit and expressed as pg/mL.
Measured: baseline, week 6 and week 12 (end of the treatment)
25OH-D (Total 25-OH Vitamin D)
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.
Measured: baseline, week 6, week 12 (end of the treatment)
Human Agrin (C-terminal fragment)
Serum Human Agrin (C-terminal fragment) will be quantified using the Human Agrin (C-terminal fragment) ELISA Kit and expressed as pg/mL.
Measured: baseline, week 6, week 12 (end of the treatment)
Triglyceride (TG)
Serum Triglyceride (TG) levels will be measured using Triglyceride (TG) Colorimetric Assay Kit and expressed as mmol/L.
Measured: baseline, week 6, week 12 (end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Dec 2025
- Primary completion30 Aug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for Sarcopenia in ElderlyStudies 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, Care provider, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Cavarape, M.D., Principal investigator, Azienda Sanitaria Universitaria del Friuli Centrale (ASU FC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356440
- Sponsor's protocol ID
- CEUR-2024-Sper-39
- Acronym
- SARC-PEA
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akune T, Muraki S, Oka H, Tanaka S, Kawaguchi H, Tokimura F, Yoshida H, Suzuki T, Nakamura K, Yoshimura N. Incidence of certified need of care in the long-term care insurance system and its risk factors in the elderly of Japanese population-based cohorts: the ROAD study. Geriatr Gerontol Int. 2014 Jul;14(3):695-701. doi: 10.1111/ggi.12155. Epub 2013 Sep 11.
PubMed 24020635Anagnostis P, Dimopoulou C, Karras S, Lambrinoudaki I, Goulis DG. Sarcopenia in post-menopausal women: Is there any role for vitamin D? Maturitas. 2015 Sep;82(1):56-64. doi: 10.1016/j.maturitas.2015.03.014. Epub 2015 Mar 27.
PubMed 25882761Bauer J, Biolo G, Cederholm T, Cesari M, Cruz-Jentoft AJ, Morley JE, Phillips S, Sieber C, Stehle P, Teta D, Visvanathan R, Volpi E, Boirie Y. Evidence-based recommendations for optimal dietary protein intake in older people: a position paper from the PROT-AGE Study Group. J Am Med Dir Assoc. 2013 Aug;14(8):542-59. doi: 10.1016/j.jamda.2013.05.021. Epub 2013 Jul 16.
PubMed 23867520Beasley JM, Wertheim BC, LaCroix AZ, Prentice RL, Neuhouser ML, Tinker LF, Kritchevsky S, Shikany JM, Eaton C, Chen Z, Thomson CA. Biomarker-calibrated protein intake and physical function in the Women's Health Initiative. J Am Geriatr Soc. 2013 Nov;61(11):1863-71. doi: 10.1111/jgs.12503. Epub 2013 Oct 28.
PubMed 24219187Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
PubMed 27897430Behrouzi P, Grootswagers P, Keizer PLC, Smeets ETHC, Feskens EJM, de Groot LCPGM, van Eeuwijk FA. Dietary Intakes of Vegetable Protein, Folate, and Vitamins B-6 and B-12 Are Partially Correlated with Physical Functioning of Dutch Older Adults Using Copula Graphical Models. J Nutr. 2020 Mar 1;150(3):634-643. doi: 10.1093/jn/nxz269.
PubMed 31858107Bischoff-Ferrari HA, Orav JE, Kanis JA, Rizzoli R, Schlogl M, Staehelin HB, Willett WC, Dawson-Hughes B. Comparative performance of current definitions of sarcopenia against the prospective incidence of falls among community-dwelling seniors age 65 and older. Osteoporos Int. 2015 Dec;26(12):2793-802. doi: 10.1007/s00198-015-3194-y. Epub 2015 Jun 12.
PubMed 26068298Boutry-Regard C, Vinyes-Pares G, Breuille D, Moritani T. Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation Increases Muscle Strength in Elderly Adults with Limited Mobility: A Randomized Controlled Trial. Nutrients. 2020 Jun 23;12(6):1866. doi: 10.3390/nu12061866.
PubMed 32585837Bradlee ML, Mustafa J, Singer MR, Moore LL. High-Protein Foods and Physical Activity Protect Against Age-Related Muscle Loss and Functional Decline. J Gerontol A Biol Sci Med Sci. 2017 Dec 12;73(1):88-94. doi: 10.1093/gerona/glx070.
PubMed 28549098Chanet A, Verlaan S, Salles J, Giraudet C, Patrac V, Pidou V, Pouyet C, Hafnaoui N, Blot A, Cano N, Farigon N, Bongers A, Jourdan M, Luiking Y, Walrand S, Boirie Y. Supplementing Breakfast with a Vitamin D and Leucine-Enriched Whey Protein Medical Nutrition Drink Enhances Postprandial Muscle Protein Synthesis and Muscle Mass in Healthy Older Men. J Nutr. 2017 Dec;147(12):2262-2271. doi: 10.3945/jn.117.252510. Epub 2017 Aug 23.
PubMed 28835387Chang SS, Chen LH, Huang KC, Huang SW, Chang CC, Liao KW, Hu EC, Chen YP, Chen YW, Hsu PC, Huang HY. Plant-based polyphenol rich protein supplementation attenuated skeletal muscle loss and lowered the LDL level via gut microbiota remodeling in Taiwan's community-dwelling elderly. Food Funct. 2023 Oct 16;14(20):9407-9418. doi: 10.1039/d3fo02766j.
PubMed 37795525Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PubMed 24461239Cho MR, Lee S, Song SK. A Review of Sarcopenia Pathophysiology, Diagnosis, Treatment and Future Direction. J Korean Med Sci. 2022 May 9;37(18):e146. doi: 10.3346/jkms.2022.37.e146.
PubMed 35535373Coelho-Junior HJ, Calvani R, Goncalves IO, Rodrigues B, Picca A, Landi F, Bernabei R, Uchida MC, Marzetti E. High relative consumption of vegetable protein is associated with faster walking speed in well-functioning older adults. Aging Clin Exp Res. 2019 Jun;31(6):837-844. doi: 10.1007/s40520-019-01216-4. Epub 2019 May 21.
PubMed 31115875Cox NJ, Bowyer RCE, Ni Lochlainn M, Wells PM, Roberts HC, Steves CJ. The composition of the gut microbiome differs among community dwelling older people with good and poor appetite. J Cachexia Sarcopenia Muscle. 2021 Apr;12(2):368-377. doi: 10.1002/jcsm.12683. Epub 2021 Feb 13.
PubMed 33580637
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Vegetable Protein-enriched Biscuits and Vitamin D Supplementation on the Progression of Sarcopenia in Elderly Subjects
- ClinicalTrials.gov ID
- NCT07356440
- Acronym / sponsor ID
- SARC-PEA / CEUR-2024-Sper-39
- Conditions
- Sarcopenia in Elderly, Sarcopenia, Nutritional Intervention, Microbiome Analysis, Muscle Mass and Strength, Biomarkers / Blood
- Keywords
- sarcopenia, elderly, pea proteins, vitamin D, snack
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of UdineUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 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.
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.
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:
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein-enriched biscuit + Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 supplement, Other: Protein-enriched biscuitsParticipants 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. |
| Control Biscuit + Placebo Oil | Placebo comparator | Other: Control biscuit, Other: Placebo oilParticipants 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). |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
- Body mass index ≥19 <30 kg/m2
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| Vitamin D3 supplementTwo daily drops of vitamin D3 dissolved in extra virgin olive oil. Used in the Experimental Arm. | Dietary supplement | Protein-enriched biscuit + Vitamin D3 |
| Protein-enriched biscuitsDaily portion (50 g) of biscuits made with wheat flour and pea protein hydrolysate. Used in the Experimental Arm. | Other | Protein-enriched biscuit + Vitamin D3 |
| Control biscuitDaily portion (50 g) of control biscuits made with wheat flour, without pea protein hydrolysate. | Other | Control Biscuit + Placebo Oil |
| Placebo oilTwo daily drops of placebo oil (extra virgin olive oil without vitamin D3). | Other | Control Biscuit + Placebo Oil |
Primary outcome
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.
19 secondary outcomes
Muscle strenght
Time frame: 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)
C-Reactive protein (CRP)
Time frame: 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)
Nutritional intake
Time frame: Baseline, week 6 and week 12 (end of the treatment)
Nutritional habits
Time frame: Enrollment
Quality of life of sarcopenic patients
Time frame: Baseline, week 6 and week 12 (end of the treatment)
Mini Nutritional Assessment (MNA®)
Time frame: At the screening
Mini Mental State Examination (MMSE)
Time frame: At the screening
Body mass index (BMI)
Time frame: 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)
Tumor Necrosis Factor-alpha (TNF-α)
Time frame: baseline, week 6, week 12 (end of the treatment)
Leptin
Time frame: baseline, week 6, week 12 (end of the treatment)
IGF-1
Time frame: Baseline, week 6, week 12 (end of the treatment)
Albumin
Time frame: baseline, week 6, week 12 (end of the treatment)
Oxidized LDL (oxLDL)
Time frame: 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)
Human Agrin (C-terminal fragment)
Time frame: baseline, week 6, week 12 (end of the treatment)
Triglyceride (TG)
Time frame: baseline, week 6, week 12 (end of the treatment)
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 27 Jul 2026.
- Background: PubMed 24020635Akune T, Muraki S, Oka H, Tanaka S, Kawaguchi H, Tokimura F, Yoshida H, Suzuki T, Nakamura K, Yoshimura N. Incidence of certified need of care in the long-term care insurance system and its risk factors in the elderly of Japanese population-based cohorts: the ROAD study. Geriatr Gerontol Int. 2014 Jul;14(3):695-701. doi: 10.1111/ggi.12155. Epub 2013 Sep 11.
- Background: PubMed 25882761Anagnostis P, Dimopoulou C, Karras S, Lambrinoudaki I, Goulis DG. Sarcopenia in post-menopausal women: Is there any role for vitamin D? Maturitas. 2015 Sep;82(1):56-64. doi: 10.1016/j.maturitas.2015.03.014. Epub 2015 Mar 27.
- Background: PubMed 23867520Bauer J, Biolo G, Cederholm T, Cesari M, Cruz-Jentoft AJ, Morley JE, Phillips S, Sieber C, Stehle P, Teta D, Visvanathan R, Volpi E, Boirie Y. Evidence-based recommendations for optimal dietary protein intake in older people: a position paper from the PROT-AGE Study Group. J Am Med Dir Assoc. 2013 Aug;14(8):542-59. doi: 10.1016/j.jamda.2013.05.021. Epub 2013 Jul 16.
- Background: PubMed 24219187Beasley JM, Wertheim BC, LaCroix AZ, Prentice RL, Neuhouser ML, Tinker LF, Kritchevsky S, Shikany JM, Eaton C, Chen Z, Thomson CA. Biomarker-calibrated protein intake and physical function in the Women's Health Initiative. J Am Geriatr Soc. 2013 Nov;61(11):1863-71. doi: 10.1111/jgs.12503. Epub 2013 Oct 28.
- Background: PubMed 27897430Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
- Background: PubMed 31858107Behrouzi P, Grootswagers P, Keizer PLC, Smeets ETHC, Feskens EJM, de Groot LCPGM, van Eeuwijk FA. Dietary Intakes of Vegetable Protein, Folate, and Vitamins B-6 and B-12 Are Partially Correlated with Physical Functioning of Dutch Older Adults Using Copula Graphical Models. J Nutr. 2020 Mar 1;150(3):634-643. doi: 10.1093/jn/nxz269.
- Background: PubMed 26068298Bischoff-Ferrari HA, Orav JE, Kanis JA, Rizzoli R, Schlogl M, Staehelin HB, Willett WC, Dawson-Hughes B. Comparative performance of current definitions of sarcopenia against the prospective incidence of falls among community-dwelling seniors age 65 and older. Osteoporos Int. 2015 Dec;26(12):2793-802. doi: 10.1007/s00198-015-3194-y. Epub 2015 Jun 12.
- Background: PubMed 32585837Boutry-Regard C, Vinyes-Pares G, Breuille D, Moritani T. Supplementation with Whey Protein, Omega-3 Fatty Acids and Polyphenols Combined with Electrical Muscle Stimulation Increases Muscle Strength in Elderly Adults with Limited Mobility: A Randomized Controlled Trial. Nutrients. 2020 Jun 23;12(6):1866. doi: 10.3390/nu12061866.
- Background: PubMed 28549098Bradlee ML, Mustafa J, Singer MR, Moore LL. High-Protein Foods and Physical Activity Protect Against Age-Related Muscle Loss and Functional Decline. J Gerontol A Biol Sci Med Sci. 2017 Dec 12;73(1):88-94. doi: 10.1093/gerona/glx070.
- Background: PubMed 28835387Chanet A, Verlaan S, Salles J, Giraudet C, Patrac V, Pidou V, Pouyet C, Hafnaoui N, Blot A, Cano N, Farigon N, Bongers A, Jourdan M, Luiking Y, Walrand S, Boirie Y. Supplementing Breakfast with a Vitamin D and Leucine-Enriched Whey Protein Medical Nutrition Drink Enhances Postprandial Muscle Protein Synthesis and Muscle Mass in Healthy Older Men. J Nutr. 2017 Dec;147(12):2262-2271. doi: 10.3945/jn.117.252510. Epub 2017 Aug 23.
- Background: PubMed 37795525Chang SS, Chen LH, Huang KC, Huang SW, Chang CC, Liao KW, Hu EC, Chen YP, Chen YW, Hsu PC, Huang HY. Plant-based polyphenol rich protein supplementation attenuated skeletal muscle loss and lowered the LDL level via gut microbiota remodeling in Taiwan's community-dwelling elderly. Food Funct. 2023 Oct 16;14(20):9407-9418. doi: 10.1039/d3fo02766j.
- Background: PubMed 24461239Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
- 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. This study is not recruiting at the moment.
Alessandro Cavarape, M.D. principal investigator
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3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 supplement and Protein-enriched biscuits in people with Sarcopenia in Elderly and Sarcopenia, run by University of Udine at 3 sites in Italy.
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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
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 Appendicular Skeletal Muscle Index (ASMI) (time frame: Screening, baseline, week 6 and week 12 (end of the treatment)). 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 NCT07356440, which also lists 67 linked publications.
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 27 Jul 2026.